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Clinical Reimbursement Manager, Ocrevus

Territory: Boston

Territory covers Boston to Maine

The Clinical Reimbursement Manager (CRM) is a newly created position charged with educating on the clinical profile, the approved infusion process, and compliantly supporting customers with patient specific access needs for the benefit of patients and their continuity of care.

This role reports to the Clinical Reimbursement Area Manager (CR-AM), Multiple Sclerosis Squad. The CRM brings clinical, access and reimbursement expertise to the field and internal teams. They are an invaluable member of the field team supporting continuity of care through clinical education, infusion access, and reimbursement expertise. The CRM helps to minimize common barriers to care in a legal and compliant way in order to support appropriate access patient access to care.

Key Duties and Responsibilities:

• Reimbursement responsibilities:

• Resolves reimbursement issues or concerns

• Communicates payor criteria/terms and practices

• Educates and assists clinics, HCP’s, infusion sites and others with payer coverage & reimbursement challenges and inaccuracies

• Proactively communicates and explains Genentech-specific reimbursement programs, policies, procedures and resources

• Acts as a subject matter expert on the local payer and reimbursement landscape

• Supports process integration to facilitate access

• Patient Navigation Liaison

• Serves as the conduit between the healthcare provider and patient navigation to support patient access to therapy

• Key link between the field and Patient Navigator

• Assists with patient specific case management needs including infusion location

• Clinical Education

• Provides clinical education in-services to customers, after a prescribing decision has been made including infusion nurses, Advanced Practice Provider’s and pharmacists.

• Ensures positive customer experiences with Genentech products by providing ongoing clinical support

• Oversees contract nurse educators

• Identifies and train’s new infusion locations

• Provides on label patient education after the clinical decision has been made

• Local advocacy development – payer, office administrator, infusion sites

• Works with relevant state, institutional or other societies

• Identifies potential access and clinical barriers to on-label brand use

• Complies with all laws, regulations and policies that govern the conduct of GNE activities and demonstrates a commitment to Genentech policies and the agile compliance philosophy

1

Job Accountabilities:

? Meets administrative expectations consistently

? Complies with all company policies and processes across all aspects of job function

? Business travel by air or car is regularly required

? This is a field-based customer engaging position

Competencies

• Communication – Listens well; expresses ideas fluently and logically; is open to input and demonstrates integrity – Consistently communicates with field partners and internal partners

• Technical and Business Expertise – Clinical education of HCP, office staff, infusion facilities – Expertise in managed markets, reimbursement and patient services - Applies emerging knowledge and trends - Builds strong relationships - Contributes to expertise within and beyond assigned area

• Strategic agility – Articulates wise, long-term objectives and strategies - Balances what will pay off in the short run with what will provide long-term improvements.

• Teamwork and Collaboration – Works closely and professionally with all members of the MS/NMO teams in the field and inhouse. Pulls appropriate team members together for expertise and problem solution

• Achieving Results -Accountable for achieving or exceeding goals and meeting or exceeding expectations of the role on a consistent basis.

Qualifications

• Bachelor’s Degree required

• Masters degree in Science, MBA or other related graduate-level degree is preferred

• 5 or more years work experience

• 5 or more years of clinical experience in Multiple Sclerosis, Neurology, Immunology and/or infusion related products preferred.

• A minimum of 2 or more years direct experience with managed care and reimbursement is preferred, either directly within/from the pharmaceutical/biotech industry or relevant, large- scale practice management

• Must demonstrate excellent working knowledge of reimbursement and the practice management and managed markets environment

• Previous experience in Neurology therapeutic area(s) is strongly preferred

• Previous experience with both private & public payers is preferred

• Previous experience in other functions in the pharmaceutical/biotech industry is a plus, e.g. product marketing, managed care marketing, field sales/sales management, field account management, etc.

• Proven track record for consistently meeting or exceeding goals and objectives

• Previous experience in completing & implementing attainable business plans

• Previous work or clinical specific experience in the pharmaceutical, biotech, or related industry is preferred

• Must live within 60 miles of the territory

This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business. This is a remote position.

Clinical Reimbursement Manager, Ocrevus

Territory: Albany, NH, VT and Western MA

The Clinical Reimbursement Manager (CRM) is a newly created position charged with educating on the clinical profile, the approved infusion process, and compliantly supporting customers with patient specific access needs for the benefit of patients and their continuity of care.

This role reports to the Clinical Reimbursement Area Manager (CR-AM), Multiple Sclerosis Squad. The CRM brings clinical, access and reimbursement expertise to the field and internal teams. They are an invaluable member of the field team supporting continuity of care through clinical education, infusion access, and reimbursement expertise. The CRM helps to minimize common barriers to care in a legal and compliant way in order to support appropriate access patient access to care.

Key Duties and Responsibilities:

• Reimbursement responsibilities:

• Resolves reimbursement issues or concerns

• Communicates payor criteria/terms and practices

• Educates and assists clinics, HCP’s, infusion sites and others with payer coverage & reimbursement challenges and inaccuracies

• Proactively communicates and explains Genentech-specific reimbursement programs, policies, procedures and resources

• Acts as a subject matter expert on the local payer and reimbursement landscape

• Supports process integration to facilitate access

• Patient Navigation Liaison

• Serves as the conduit between the healthcare provider and patient navigation to support patient access to therapy

• Key link between the field and Patient Navigator

• Assists with patient specific case management needs including infusion location

• Clinical Education

• Provides clinical education in-services to customers, after a prescribing decision has been made including infusion nurses, Advanced Practice Provider’s and pharmacists.

• Ensures positive customer experiences with Genentech products by providing ongoing clinical support

• Oversees contract nurse educators

• Identifies and train’s new infusion locations

• Provides on label patient education after the clinical decision has been made

• Local advocacy development – payer, office administrator, infusion sites

• Works with relevant state, institutional or other societies

• Identifies potential access and clinical barriers to on-label brand use

• Complies with all laws, regulations and policies that govern the conduct of GNE activities and demonstrates a commitment to Genentech policies and the agile compliance philosophy

Job Accountabilities:

? Meets administrative expectations consistently

? Complies with all company policies and processes across all aspects of job function

? Business travel by air or car is regularly required

? This is a field-based customer engaging position

Competencies

• Communication – Listens well; expresses ideas fluently and logically; is open to input and demonstrates integrity – Consistently communicates with field partners and internal partners

• Technical and Business Expertise – Clinical education of HCP, office staff, infusion facilities – Expertise in managed markets, reimbursement and patient services - Applies emerging knowledge and trends - Builds strong relationships - Contributes to expertise within and beyond assigned area

• Strategic agility – Articulates wise, long-term objectives and strategies - Balances what will pay off in the short run with what will provide long-term improvements.

• Teamwork and Collaboration – Works closely and professionally with all members of the MS/NMO teams in the field and inhouse. Pulls appropriate team members together for expertise and problem solution

• Achieving Results -Accountable for achieving or exceeding goals and meeting or exceeding expectations of the role on a consistent basis.

Qualifications

• Bachelor’s Degree required

• Masters degree in Science, MBA or other related graduate-level degree is preferred

• 5 or more years work experience

• 5 or more years of clinical experience in Multiple Sclerosis, Neurology, Immunology and/or infusion related products preferred.

• A minimum of 2 or more years direct experience with managed care and reimbursement is preferred, either directly within/from the pharmaceutical/biotech industry or relevant, large- scale practice management

• Must demonstrate excellent working knowledge of reimbursement and the practice management and managed markets environment

• Previous experience in Neurology therapeutic area(s) is strongly preferred

• Previous experience with both private & public payers is preferred

• Previous experience in other functions in the pharmaceutical/biotech industry is a plus, e.g. product marketing, managed care marketing, field sales/sales management, field account management, etc.

• Proven track record for consistently meeting or exceeding goals and objectives

• Previous experience in completing & implementing attainable business plans

• Previous work or clinical specific experience in the pharmaceutical, biotech, or related industry is preferred

• Must live within 60 miles of the territory

This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business. This is a remote position.

The Project Manager (PM) will support projects to include pipeline, product care, technology and/or continuous improvement initiatives in our Device area.  In partnership with the Technical Development Team Lead (TDTL) and Device Team Leader (DTL), the Project Manager (PM) will facilitate translation of the device strategy into a plan and drive execution at the Team level.  The Project Manager responsibilities will focus in 3 key areas to enable execution of the device strategy within the agreed-upon constraints of scope, time and cost:

• Facilitate effective planning with the Team to define “inspection ready” Design and Development Plans
• Drive execution of Team activities to meet project and design control deliverables
• Drive closure of Team actions to enable advancement to next stage through an effective Design Review process

The PM will proactively drive planning and execution of the device strategy through the effective use of PM best practices and integration of Quality System Requirements (QSR) including design controls into Team activities.  This will involve oversight of project plan execution through the close monitoring of critical path activities and the creation of contingency plans to resolve issues and achieve deliverables. 

Qualifications

The level of the position will depend on the qualifications of the selected candidate.

• Bachelor's degree or higher, preferably in an Engineering or related discipline.
• 5+ years of relevant post-Bachelor's experience; 8+ years for the senior level.
• Experience in a multi-site global company in the medical device, pharmaceutical or biopharmaceutical industry preferred.  
• Drug and/or medical device development and commercialization experience, preferably with Combination Products.
• Demonstrated experience leveraging Project Management best practices:  communication, scheduling, budget planning, resource planning, team building  and risk management. 
•  PMP certification considered an asset.
•  Solid knowledge and understanding of 21CFR820.30 design control requirements strongly preferred.
• Proficiency with software tools such as Microsoft Office (Project & Excel), Google, WebEx, Visio, Planisware.
• Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, ever-changing, team-based environment.
• Excellent oral and written communication skills (listening, negotiation, presentation, organizational and relationship-building).
• Ability to effectively communicate in a highly matrixed organization and with external parties.

Job Responsibilities:

• Strengthen the overall Engineering community by building bridges and collaborating with Principal and Senior Engineers in other Infrastructure Solution Areas

• Interact with Senior internal and external personnel on significant technical matters as it relates to priority objectives

• Contribute to determining success criteria for the evaluation of promising solutions/technologies via Proofs of Concept (PoCs) and feasibility studies across two or more areas within Collaboration and Facilities IT space, as they related to meeting Roche’s business needs

• Architect, design, build, test, and deploy (first-time) integrated, resilient and reliable solutions in multiple solution areas across the entire Collaboration and Facilities IT Solution space

• Manage small-to-medium sized technical teams for specific objectives in medium-to-large initiatives (projects, lifecycle work, PoCs, etc.) and to provide the expert guidance required to drive technical developments in these initiatives

• Advise, influence, collaborate with, and synthesize feedback from various IT partners

• Ensure solutions in collaboration and Facilities IT space align and adhere to the organization’s Technical Architecture Framework (TAF) policies, standards and directions

• Map the technology roadmaps into portfolio projects/activities and to estimate resources, dependencies, risks, and timelines required to deliver these projects/activities successfully

• Contribute and/or write position papers, white papers, best practices and use cases for their infrastructure solution space

• Stay abreast of operational challenges and opportunities related to Collaboration and Facilities IT space

• Partner effectively with operational support teams to provide efficient internal/external escalations and problem/incident resolutions

• Ensure solutions implemented fit within the Quality/Regulatory standards, as applicable

Job Requirements/Qualifications:

• Bachelors Degree and at least 4 years experience working in one or more multinational work environments.

• Pharma/biotech/healthcare industry experience is a plus as a senior level Infrastructure Engineer in the role of Facilities IT/ Collaboration Engineer.

• Deep knowledge of the following technologies:

  • Cisco Telepresence and Video Conference solutions.

  • Unified Messaging, preferably based on gMail.

  • IT Audio Visual design.

  • Digital Signage solutions.

  • Whiteboard solutions

  • Systems Integration solutions

  • Webcast

  • Audio Visual equipment for auditoriums.

  • Video and Audio conferencing

  • Working space/Shared spaces design that enhance collaboration.

• Technical experience in deployment and support of:

  • Auditorium audio visual solutions;

  • Digital signage solutions for multinational environments;

  • Systems Integrated solutions such as whiteboards, collaboration technologies, display, video walls and content sharing;

  • Centralized video clustering solutions where the rooms are distributed in multiple countries in a region;

  • Telepresence solutions where the rooms are distributed in multiple countries in a region.

• Strong interpersonal skills

• Well demonstrated customer & delivery focus

• Strong customer engagement and presentation skills with the ability to communicate across all levels (senior and/or large audiences)

• Ability to work effectively with team members and virtual teams from different locations and different cultural background

• Ability to function strategically and independently with minimal supervision

• Excellent problem solving and decision-making skills

• Strong oral and written communication skills in English (mandatory) with German, Spanish or Chinese (Mandarin) as a significant plus

• Proven project and time management skills

• Moderate to extensive travel required and ability to work across multiple time zones, including some on-call and extended hours work, as required

• CCNA Collaboration/CCNP Collaboration

The Solution Architect HR Technology is a member of the Pharma Informatics Team and serves as a trusted IT strategist for Genentech Human Resources.  They will be responsible for driving the development of an IT strategic roadmap for Genentech Human Resources and will work with strategic governance group(s), the senior management team, management teams, and staff across the organisation to identify technology which enables Genentech HR to achieve its vision and strategy.

In addition, the Solution Architect for HT Technology will represents Genentech HR to assert its priorities within Group Informatics and will ensure the proper alignment of the objectives of Genentech HR with IT. They will provide Genentech HR a window to key innovative technology trends and evolution of HR technology solutions, which has the potential to accelerate the fulfillment of Genentech HR strategic vision. Also, they will provide continuing communication to ensure Genentech HR has an overview of the progress of current IT innovation(s). They will partner with peer organizations within Group Informatics supporting the HR landscape globally to ensure use of global solutions where possible as well as sharing information about our Genentech solutions and innovations. The HR Solution Architect will provide guidance and linkage to Group Function HR Informatics to ensure internal alignment on architecture patterns and platforms as well as reuse of solutions and components.

Responsibilities:

• Develops IT Strategy & Roadmap inclusive of critical investment plan aligned with the strategic needs of Genentech HR in close partnership with key stakeholders from Genentech HR and corresponding Group Informatics teams.

• Provides strategic consultation to assigned business customers in defining or designing HR solutions to enhance the employee experience and augment Genentech as a great place to work, as well as using customer requirements in researching, identifying and internally marketing enabling technologies. 

• Assesses current state of solutions, defines future state needs, identifies gaps and recommends new technology solutions and strategic business execution improvements

• Interface with Architects, Technical Leads and Developers to drive technical solutions, estimate work efforts, define milestones and provide hands on technical leadership.

• Highlights short-term trade-offs vs long-term commitments and where those are worth implementing or not. Ensures that the solutions are scalable (technology), efficient (process), effective (cost), and supportable

• Conduct solution architecture research, market assessment and facilitating solution application selections and experiments / pilots

• Formulate business and logical solution architectures comprised of local and global functional capabilities and drive implementation of agreed technology solutions

• Ensures the HR solution architecture remain current with the business needs and directs the development of architecture activities and projects, while aligning with local and global technology & solution roadmaps

• Partners with other architects and solution owners to influence standards and strategies for the enterprise in the HR space.

• Work with business and IT teams to understand the needs for complex data/BI models (that leverage statistics, time series, machine learning, textual analysis, prediction, etc.), define prototypes, collect/curate large data sets, Implement/evaluate/tune data models and drive valuable insights through iteration.

Qualifications:

• Bachelor's degree in computer science, systems analysis or a related study, or equivalent experience

• 12+ years of relevant work experience including leadership and architecture level experience. The person must have demonstrated an ability to think strategically and translate plans into actions and drives them to completion

• Hands-on experience in designing and deploying HR IT solutions for large enterprises

• Technical expertise regarding data models, database design development, data mining, segmentation techniques and data visualization

• Expertise in multiple technologies domains

• Ability to quickly comprehend the functions and capabilities of new technologies

• Remains “evergreen” and keeps up-to-date with technology trends and emerging technologies

• Ability to understand the long-term ("big picture") and short-term perspectives of situations.

• Strong leadership skills and demonstrated ability to work across organizations and building partnerships

• Demonstrated effective oral, written, public, and interpersonal communication skills

• Demonstrated ability to frame complex issues and persuade a wide and diverse audience, effective at stakeholder management and influence

• Sound and mature business judgment capable of contributing on a broad range of topics, not just technology issues

• Ability to gain immediate respect and credibility with colleagues and stakeholders

• Teamplayer and creative problem solver who can uncover innovative ways to drive business value

• Influencer and negotiator who can align key stakeholders to a shared vision and roadmap

• Accountable, results oriented & comfortable with a demanding set of internal and external customers.

• Remains unbiased toward any specific vendor or technology choice; is more interested in solving the business problem than the technology itself

NOTE: This position is not eligible for relocation

Job Overview:

The Pharma Informatics gRED IT group seeks a talented and motivated Cloud and DevOps Engineer. Your responsibilities will include partnering with a diverse team of scientists and IT staff to design, deploy, maintain and integrate Cloud and DevOps solutions. The job will utilize and build on your experience in cloud computing, automation, high performing computing and DevOps.

Genentech Research & Early Development (gRED) is a world class scientific organization that consistently leads the industry in Pharmaceutical and Biotech discovery. gRED's primary mission is to identify and develop drug target candidates that lead to novel therapies to treat patients with serious or life-threatening medical conditions. gRED encourages an open, academic-like atmosphere and frequently publishes in top-tier, peer reviewed journals.

Key Responsibilities:

? Use automation and CI/CD methods to develop and deploy private and public cloud applications in support of various projects

? Assist with DevOps support on our standard private and public cloud, and high performance computing (HPC) platforms

? Work directly with software developers, technical architects and support personnel to define, document, and manage requirements

? Develop tooling and processes to improve and streamline customer experience

? Troubleshoot issues with production environments, escalating as needed to Engineering team

? Support infrastructure maintenance and enhancement activities from an operational perspective

? Support additional operational efforts as appropriate

Qualifications/Requirements:

? B.S. or B.A. degree in information systems, engineering, or computer science required

? 5-7+ years technical IT work experience (3-5+ years w/ advanced degree)

? 2+ years experience supporting DevOps in Cloud and/or HPC environments

? Proficient skills in at least one of the following languages: Python, Java, Ruby, bash

? Proficient with git and git workflows

? Hands-on experience with at least one cloud provider AWS, GCP, or Azure

? Experience with Infrastructure as Code tools such as CloudFormation, Terraform, Ansible, Chef, Puppet

? Understanding and hands-on experience with container technologies including Docker and/or Singularity is a must

? Experience with CI/CD tools to automate testing and deployment, such as Jenkins or Travis CI

? Excellent interpersonal skills with your own team, technical IT partners, and customers

? Can communicate effectively in both written and verbal form to non-technical audiences

? Plus: Experience with deployment of scientific applications

? Plus: Experience working with Agile/Scrum

NOTE: This position is not eligible for relocation

The Position:

If you are passionate about customer service, love technology, and want to have some fun while you work, then this is the role for you!  The Site Support Tech Lead is responsible for providing Specialized IT support and leadership in a GxP environment to our Pharma user community. 

This is an essential role in the North America Pharma User Services organization without which we would not be able to provide the amazing level of customer service that our community has come to expect. This position reports to the IT Manager of Focused Onsite Specialized Services and will be based in Oceanside Ca.

Responsibilities:

• Escalation Management:
  • First point of escalation for team members
  • Troubleshoots to resolve escalation on own or with peer tech leads
  • Engages the RSC incident management process and or manager as required
  • Technical coaching and mentoring for less experienced staff members
  • Make independent decisions to resolve complex technical issues
  • Comfortable presenting technical solutions for difficult to solve problems to all levels of peers and leadership.
• KPI and SLA Management:
  • Monitors the team’s workload to ensure team key performance indicator (KPI) metrics stay on track throughout the day.
  • Working in partnership with our Organizations OE expert obtains and provides feedback on how metrics are reported / recorded
  • Must be knowledgeable of ITIL and industry best practices
• Infrastructure Management:
  • Extensive management of Active directory, GPP’s, GPO’s and associated tools
  • Manage user and computer configurations for multiple locations leveraging tools such as PowerShell, SCCM, OS Patching etc.
  • Must be able to thrive in a matrixed multi-functional support model. Frequently interfacing with varied groups and teams in multiple time zones across the globe.
  • Networking: Provide support for advanced network desktop configurations: LAN, WAN, wireless, VPN.
• Incident Management SME:
  • Serves as ticketing application (currently HPSM soon to be Service Now) SME for the team.
  • Ensures tickets are assigned and routed to the correct groups to ensure compliance with our Service Level Agreements (SLA’s)
• Knowledge Management:
  • Works with solution owner SME to document resolutions, workarounds, and frequently asked questions in HPSM / Service Now knowledge management solution articles.
• Project Management: 
  • Stand-ins for manager as a delegate in project meetings when required. 
  • Participates in site leadership team meetings when required.
  • Collaborate with peers to identify and implement innovative, high quality solutions for our customers.
  • Ability to lead small / medium project teams.
• Drive and recommend work process improvements.
• Assist with new service pilots, deployments, and configurations.
• Understand and adhere to incident management, request fulfillment, and knowledge management processes.
• Provide technical support for:
  • Applications:  E-mail, calendar, office applications (word processing, spreadsheets, presentations, project), browsers, as well as department-specific applications.
  • Client technologies:  Macintosh, Windows, tablets, cell phones, wireless devices, video/audio conferencing and printing solutions
  • Networking: Provide support for advanced network desktop configurations: LAN, WAN, wireless, VPN.
• Provide Support to specialized GxP environments
  • Provide extensive support for Manufacturing and LAB computing environments
  • Act as a change owner / approver for IT change tasks as they relate to both IT GxP and non GxP changes.
  • Skilled in executing and authoring system Validation / qualification documents
  • Partner with QC laboratory Scientist, QC leadership, external vendors, and global IT counterparts in FPP to establish QCIT standards, perform GxP assessments, application testing, and Computer System Validation
  • Manage / Support Patching / Security for All Lab systems - Genentech sites
• Provide support to mobile users who work at home, travel, or work from a remote office.
• Identify, troubleshoot, and resolve hardware and software application conflicts.
• Install and upgrade software and operating systems as needed
• Provide status updates to the users per our SLAs

Qualifications/requirements:

• Bachelor’s degree in computer science, information technology, or other relevant field preferred
• 7-10 years of experience supporting Windows, Macintosh, mobility platforms, Linux, Microsoft Office suite of applications and Google suite of products (gMail, gCalendar, gDrive, etc.) and intermediate to advanced network concepts and troubleshooting tools (TCP/IP, remote access solutions, network file shares, tracert, netstat, etc.).
• MCITP, MCDST, A+ and other ITIL Certifications preferred.
• Interested in learning how to use data (metrics and reports) to drive better service, products, and processes.
• Well versed in ITIL core processes:  Incident Management (IM), Request Management (RM), and Knowledge Management (KM)
• ITIL Certifications a plus
• Demonstrated experience in PowerShell and other Microsoft tools
• SCCM expertise a plus
• Superior customer service skills with demonstrated leadership skills
• The position requires occasional off hours support and may be required to be on call
• Travel requirement of up to 30%

The Paralegal I will provide a high level of administrative support in all facets of US Patent Law to three or more patent attorneys in the Genentech Legal Department. Ideal candidate must possess advanced knowledge of Patent and Trademark (PTO) rules and procedures. Candidate must be proficient at navigating EFS, PAIR and EPAS. Strong knowledge of and ability to keep abreast of 37 C.F.R. rules and MPEP rules is essential.

 

Responsibilities:

• Preparing and filing US Patent correspondence, transmittal documents, and formality documents (Declarations and Assignments).
• Liaise with Inventors to obtain signatures and ensure these documents are received and filed in a timely manner.
• Correspond with Foreign Associates and Outside Counsel relating to all Patent Prosecution matters.
• Generate weekly docket reports and coordinate with attorneys, colleagues, Foreign Associates and Outside Counsel to ensure all deadlines are met.
• Prepare and manage Information Disclosure statements, including the ability to comprehensively review art cited across large patent family/portfolios.
• Create, organize and maintain US and foreign patent files (paper and electronic).

Job Requirements:

• A minimum of 5-9 years of experience in patent prosecution work required.
• High school diploma required. Bachelor’s degree preferred.
• Required technical capabilities in Microsoft Word, Outlook and Adobe Acrobat Professional as well as basic knowledge of Excel and PowerPoint.
• Experience using the USPTO electronic filing system as well as a patent docketing system (IP manager, CPI, CPA, Memotech etc.) is required.
• Experience with First to File, Google Calendar and Lecorpio (IDS) is extremely beneficial.
• Strong skills in the following areas:
  • Organization, attention to detail, and analytical abilities
  • Effective written and verbal communications to include clarity and tact
  • Ability to perform and prioritize multiple tasks simultaneously, efficiently, and collaboratively in accordance with deadlines.
  • Proactive, self-disciplined and able to work independently with minimal supervision.
• Contribute to the general needs of the Patent and Legal groups. Some examples include providing back-up assistance to peers, and participating on special projects and/or other activities as requested.

Position Summary:

This position serves as the primary Quality and Compliance Office (QCO) representative and single point of contact for GCP/GVP compliance support for Genentech Early Development (ED) therapeutic area and clinical study teams. The key activity of the role is providing expertise and guidance regarding regulatory requirements, GCP guidelines and Roche Standard Operating Procedures (SOPs) for the conduct of clinical studies. As an expert, the Clinical Quality Compliance Lead (CQCL) will utilize a risk-based strategy to prioritize QCO support activities for clinical trial activities, identify and escalate compliance issues, enable decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks.   In addition the CQCL will partner with Quality, Regulatory, Safety and other key functions to enable transparency and escalation of quality and compliance matters.   This position serves as an important conduit to the broader organization to ensure a culture of quality and compliance. Incumbent will leverage his/her compliance expertise coupled with a comprehensive understanding of the R&D landscape to proactively contribute to the Genentech Early Development organization. Incumbent will communicate and interface with a host of internal cross-functional partners, both within Genentech and other Roche functions; identifying areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance. The CQCL will actively contribute to the development and implementation of Policy/Standard Operating Process / Procedures in addition to tools, and templates deemed controlled in supporting regulatory requirements for application in drug development and clinical trial execution within the Genentech Early Development organization.

The CQCL is expected to foster an open and collaborative environment across the global site network and will ensure implementation of Global Quality (GCP/GVP/ICH), Legal and Healthcare Compliance strategies within assigned functions.

Considering local candidates only.

Purpose:

The Alliance & Partnership Lead is responsible for cultivating relationships with internal & external partners to support the advancement of the OMNI (Ophthalmology, Metabolic, Neuroscience, Immunology) Early Development clinical pipeline.  

Primary Responsibilities and Accountabilities:

This role will support gRED Clinical Operations plans for internal & external collaborations across a variety of stakeholders, including: external experts, research organizations, academic institutions and cooperative groups, as well as networking extensively within gRED, pRED, PDG, CCO and PDMA for assigned therapeutic area/s.

• Develop an overall strategy for partnership development and relationship maintenance across the clinical development life cycle to support a franchise approach to internal /external collaborations
• Support the growth of existing relationships and build new relationships in collaboration with Regional Strategy Leads
• Oversee implementation, roll-out and maintenance of partner engagement plans and tools
• At the request of the Clinical Program Leader (CPL), drive coordination of partner interactions at conferences, Investigator Meetings and site visits
• At the request of the CPL, serve as the OMNI Clinical Operations Lead for MSL interactions for assigned therapeutic areas
• Interact with pRED, PDG and PDMA to gain insight into global engagement strategies and implications for the gRED OMNI portfolio.
• Develop and maintain a network of external partners (KOLs, site experts, research organizations, Centers of Excellence, etc.) with early development capabilities aligned to the needs of the current and emerging portfolio
• Conduct and coordinate high-level assessments of site capabilities and support for the optimization of these relationships
• Act as liaison to broker relationships between key partners and study teams
• Collaborate with ECD Informatics to build and maintain external partnership intelligence for use across gRED and wider functions:
• Leverage global Roche relationships with external collaborators and ensure that potential conflicts of interest/competition are mitigated, transparent, and if necessary, escalated for appropriate management.
• Provide internal partners with transparency into gRED’s external collaborations and ensure continuity of relationships across the development lifecycle.

Alliance Management:

This role is accountable for identifying opportunities to further develop existing relationships in support of OMNI Alliance objectives:

• Participate in strategic planning meetings with the Leadership Team to define OMNI alliance strategy and ensure operational delivery
• Act as Liaison to broker relationships between key research sites and OMNI teams
• Set specific objectives and standards for each assigned alliance
• Develop and incorporate specific and measurable performance metrics and accountabilities into alliance strategies, plans and tactics
• Partner with internal stakeholders (e.g., Clinical Operations, Clinical Science) to plan and implement alliance management activities
• Collaborate with key alliance sites to drive and develop best practices

Program Planning:

This role provides landscaping and analytical input garnered through Partnership engagement activities to aid gRED Program Leadership develop strategic and operational plans for delivering on the OMNI portfolio:

• As requested by Clinical Program Leader, leverage relationships to provide therapeutic area landscaping and technical input as needed for the development of program strategy:
  • Epidemiology, standards of care, regulatory intelligence, molecule landscaping, internal & external clinical trial landscaping, early development trends, etc.
• Provide input as needed for the development of program and study operational planning:
  • program review support, enrollment workshops, country & site selection support, historical analysis

These statements are not an exhaustive list of all responsibilities, duties, and skills required of this role, but are used instead to describe the general nature and level of the work.  Different levels of responsibilities and accountabilities may be assigned to take account of the skills, capabilities and experience of the individual.

Education and Experience Required:

• Life Science degree and/or MBA or equivalent experience.
• Advanced degree in the Life Sciences or Business highly desirable.
• At least 10 years clinical development /operations experience, with deep therapeutic expertise in one or more areas.
• Experience developing successful relationships that support the business preferred (KOLs, site experts, alliances, affiliates, vendors, patient groups, etc.).

Skills and Competencies Required:

• Broad knowledge across the drug development lifecycle.
• Deep therapeutic area knowledge and expertise.
• Successful track-record of building and maintaining strong internal and external relationships
• Experience in strategic and operational planning.
• Ability to distill complex information from multiple sources and draw meaningful conclusions and insights.
• Highly effective verbal, presentation, and written communication skills.
• Strong ability to influence, motivate and command the respect of a broad stakeholder population.
• Effective team player who has the ability to work internationally with multi-cultural teams in a highly matrix based environment.
• Demonstrated customer-oriented and solutions-focused mindset.
• Proactive and self-motivated attitude.
• Willingness to challenge established practices and concepts.
• Proven ability to support innovation even if taken outside of their comfort zone.
• Demonstrated ability to drive and support change.

#LI-GREDKM2

Are you looking for an opportunity to be part of transforming the drug development process?

This Principal Project Manager role in our Personalized Healthcare (PHC) organization within Genentech/Roche Product Development is an opportunity to join a highly motivated global team that is embracing the opportunity to incorporate new technologies and data sources into the drug development process. This job will report to and work in close partnership with the Head of the Program Management Office. PHC creates opportunities to improve outcomes for patients today and in the future. 

The Product Development Personalized Healthcare (PDP) function aims to drive Roche enterprise transformation by:

• Accessing meaningful data at scale (high-dimensionality datasets with longitudinal clinical trial data, real-world data, whole genome sequencing, pathology imaging data, and digital health data)
• Applying advanced analytics to accelerate insight generation
• Feeding forward insights re: disease activity/disease characterization to inform research and development decisions which improves our internal productivity and provides evidence to inform external decision-makers including patients, healthcare providers, governments, regulators and public and private payers.

Job Responsibilities

• Guide project teams comprised of scientists and business leaders from across the globe towards planning, implementation and achievement of business objectives/outcomes set by senior managers and executives
• Develop efficient process/approaches based on business knowledge and understanding of what drives value for pharma
• Lead coordinated, thoughtful, fit-for-purpose solutions for both operations and projects

Who You Are

• Bachelors or Masters degree in life science or business with 10+ years work experience (Bachelors) or 8 years (Masters) including 5+ years leading complex projects in the pharmaceutical/biotechnology, or healthcare industry
• Strong skills in leading teams, problem solving, influencing, teamwork and communication.
• Demonstrated skill in innovation and creative approaches in building new business

process solutions.

• A self-starter who takes initiative and drives to solutions.
• Extensive experience working with functional areas with the corporate landscape, Legal, Procurement, IT, etc.
• Ability to travel domestically and internationally, approximately 4 times/year
• Ability to work flexible hours as needed in partnership with global locations, including ability to start work at 7am local time regularly

Ideal candidates will also have:

• Prior experience addressing challenges with internal and external stakeholders in the areas of data privacy, intellectual property and data regulations
• Data science and data management with a range of data types, for example clinical, imaging, claims and genomic
• Familiarity with preparing data for advanced analytic platforms and a keen interest in data science
• Drug development experience.

#LI-PDHB2

Title: Senior Medical Director, Hemophilia

                        US Medical Affairs (Hemophilia)

Function:       US Medical Affairs

Location:        South San Francisco, CA

Purpose

The Senior Medical Director at Genentech puts patients and science at the center of all actions. They drive medical tactics aimed at maximizing medical progress for patients. They collaborate to drive timely data generation and dissemination. They are expected to maintain an in-depth understanding of the medical strategy and relevant clinical and payer issues, while ensuring Genentech's partners understand key trends and shifts in the external healthcare landscape. They serve as the guardian for high standards of compliance, ethics and safety.  This position sits within a network of clinical and scientific experts, and therefore may be performing a variety of medical activities, as needed.

The Position

We are seeking a dynamic medical leader to focus in the area of Hemophilia to join the US Medical Affairs network of scientists at Genentech. The Senior Medical Director will provide exceptional clinical and scientific leadership for medical affairs activities in the area of Hemophilia and related disorders. With an aim of generating and communicating medical evidence that helps practitioners, patients and payers make good health care decisions, the successful candidate exhibits outstanding communication and leadership skills and builds strong relationships with key stakeholders in the hemophilia community.

This individual will be responsible for the execution of medical activities within the context of the US health care environment that, depending on specific areas of responsibility, may include clinical study design and monitoring; clinical and health economic data analysis, interpretation and publications; medical content development and review; clinical training and insights generation; and scientific exchange and collaboration.

This position will also represent the US Medical function within cross functional teams and initiatives at Genentech, within the Roche global organization, and in external customer facing engagements. In addition to strong communication skills, this position requires the ability to lead fit-for-purpose teams in a matrix environment, flexibility in prioritizing work, and a mindset to engage in purposeful partnerships to solve complex multi-disciplinary challenges.

As a Senior Medical Director you are expected to:

• Provide the medical perspective for the Hemophilia program and to a broader network of Medical Affairs professionals in the home and field organizations
• Design, execute, and monitor medical strategies, plans and tactics spanning the product lifecycle
• Represent Genentech Medical Affairs externally at key meetings
• Develop scientific partnerships with therapeutic area experts, medical societies, patient advocacy groups, and health care institutions
• Lead efficient implementation of medical tactics, leveraging the network of relevant expertise and insights
• Execute clinical trial activities conducted as part of Medical Affairs
• Provide expert review of medical content for medical information and educational activities
• Ensure the clinical accuracy of training material for scientific and product information and drug safety reporting to the local organization
• Provide clinically meaningful perspective for regulatory and other scientific communications
• Address access-related medical issues and opportunities
• Ensure medical and product information and communications are provided in compliance with Genentech - Roche policies
• Act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions
• Participate and thrive in an interactive, purpose driven culture

Who you are

A leader with a strong scientific and clinical background who has a passion for making medical progress for people affected by Hemophilia. You are looking for a company where you have the opportunity to positively impact peoples’ health, and where a job title does not define who you are professionally but is the starting point of what you can achieve.

Qualifications, Experience and Skills

• Board Certified physician with clinical experience in hemophilia is preferred
• Minimum 4-5 years of relevant clinical / medical pharmaceutical/biotechnology industry experience
• Experience or relevant knowledge of pre-approval drug development trials and/or post-marketing medical evidence generation, including expertise in controlled and observational study designs, data analysis, and clinical/health economic interpretations
• Understanding of the US health care environment including the payer landscape, evidence-based medicine tools and practices, and health technology assessments
• Ability to navigate complex and challenging situations and flex and thrive in an ambiguous environment

This position is located in South San Francisco and requires up to 35% time traveling.

Roche is an equal opportunity employer.

Level: E3

Franchise: RAlly (Rheumatology)

Territory: Gainesville, FL

Territory Includes: Gainesville: along I-75, Spring Hill to I-75/I-10

The Clinical Specialist, RAlly sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state.

Reports to: Melissa Furlow - Division Manager, RAlly Sales

Example Duties and Responsibilities:

• Responsible for meeting or exceeding assigned sales targets
• Develops robust territory business plans
• Develops strong and long-term relationships with customers in all assigned accounts
• Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands
• Works collaboratively with cross-functional teams including but not limited to managed care, thought leader liaisons, medical science liaisons and co-promote counterpart (Novartis).
• Monitors operating costs and compliance with territory budget
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Understand how to use/coach to the ACE Customer Engagement Framework
• Business travel, by air or car, is regularly required

Key Competency Profile:

• Technical & Business Expertise
• Inspiring & Influencing
• Achieving Results
• Decision-Making
• Teamwork & Collaboration
• Strategic Agility

You are an individual with the following qualifications and experience:

(unless stated as "preferred" or "a plus," all other criteria is required)

• Genentech sales experience preferred
• Bachelors Degree
• Average of 4 or more years' work experience
• 2 or more years of previous sales experience in the pharmaceutical, biotech, or related industry is required
• Institutional/Hospital sales and/or disease-state experience preferred
• Proven track record of meeting or exceeding objectives & goals
• Previous experience in achieving specific sales plans or other financial targets is preferred

NOTE:

This is a remote position.

This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

*LI-COMM-MG1

Ocrevus Franchise, Denver East

The Ocrevus Clinical Specialist is a field-based position. The candidate must live within 30 miles of the territory boundary. 

Ocrelizumab has been adopted by the multiple sclerosis community based on the groundbreaking randomized phase III data and desirable safety profile relative to the competition. The Ocrelizumab team has the chance to shape not only the large US market, but also the global effort - as the US is ~70% of worldwide sales. In addition, the Ocrelizumab team will chart our course in neuroscience, marking the first launch in this therapeutic area - one that we hope to grow significantly in the future. Ocrelizumab was launched in Q2 of 2017. 

This role reports to the Division Manager, Multiple Sclerosis Franchise. The Clinical Specialist, manages and develops long-term relationships with health care providers and other customers for targeted accounts in the assigned territory. Additionally, the Clinical Specialist will work closely with all other field partners

Key Duties and Responsibilities: 

• Primary point of account contact

  • Establishes and maintains productive and collaborative working relationships with cross functional groups and peers across franchises 

• Drive demand

  • Responsible for meeting or exceeding assigned sales targets

  • Develops robust territory business plans 

  • Profiles and targets key customers 

  • Develops strong and long-term relationships with customers in all assigned accounts 

• Drive persistence

• Infusion training

  • Provides product educational in-services to customers, including infusion nurses, APPs, pharmacists and physicians

• Product access discussion

• Triage (specific patient) reimbursement needs to ERS

• FPM like Activities

  • Discuss GDP

  • Discuss Provider contract

• Local advocacy Development

  • Build advocacy with Thought Leaders using on-label and PRC-approved materials

• Hospital formulary acceptance

• Presents the assigned GNE brand in a professional, compliant, ethical and effective manner; helping external customers 

• Understand the benefits and use of GNE brands 

• Complies with all laws, regulations and policies that govern the conduct of GNE activities 

Demonstrated strength in the following competencies is critical for success in this role: 

• Technical and Business Expertise (specifically, sales, infusion markets, buy and bill, specialty pharmacy and/or launch) 

• Achieving Results 

• Decision Making 

• Teamwork and Collaboration 

• Communication 

This is a remote position. 



This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business. 

Qualifications and Experience: 

 

• Bachelors Degree required, MBA or other related graduate-level degree is preferred 

• 5 or more years’ of field sales experience in the pharmaceutical/biotechnology/or other related industry with an emphasis on commercialization preferred

• Transferable experience (Infusion, Buy and Bill, Specialty Pharmacy, Launch) is preferred 

• Previous/direct managed care experience - either in account management, payer-focused marketing, or other - is preferred

• Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals required 

• Demonstrated experience successfully working and collaborating with cross-functional teams with and without authority required 

• Business travel required 

• Compliance with all laws, regulations, and policies that govern the conduct of GNE activities required

You will join Pharma Technical Development (PTDU) for a 6 month internship beginning January/February 2018. As an organization, we work to design processes to manufacture large molecule therapeutics.  Our work aims to develop processes that can be manufactured at sites worldwide in an efficient manner while keeping in mind that patient safety is our primary goal. With a thriving pipeline and limited resources, automation, data management, and business process improvement are critical to our

success. We welcome your entrepreneurial spirit and fresh perspectives to help us drive change and resolve complex and ambiguous issues.  

Specifically, this role focuses on implementing data management systems and predictive modeling to improve our business and laboratory workflows. We are looking for someone with a strong background in computer science or data science with an

interest in biotechnology. 

Your responsibilities will include:

• Improving data management systems by building a front-end web application to simplify and automate workflows
• Develop tools for predictive modeling based on large data sets

Preferred skills include:

• Front-end web development (React.js, Angular.js)
• Understanding of SQL database structures
• Data visualization techniques

Requirements

To be eligible for this position, the candidate must be currently enrolled in an accredited college or university.  Candidate must possess good problem solving, interpersonal, communication, and team skills.  Candidate must be a self-starter with a strong

focus on quality, details, and results.  Seeking candidates currently studying in computer sciences and/or engineering with an emphasis in the following majors:

• Computer Science/Engineering or related
• Bio/Chemical Engineering or related

Additional characteristics of successful candidates:

You are high-potential and love to be challenged. You thrive in an environment with minimal oversight and proactively seek to make life easier for the people you work with. You are able to communicate with clients with various backgrounds, at different

levels and quickly identify key requirements.

Design strategy and technology to build and improve an aligned global transition analysis tool. Collaborate with experts from various global sites to improve the tool's ability to predict chromatography column failure. Utilize R/Python programming skills to collect/analyze large cross-site datasets and present findings and implement improvements. Utilize data visualization software to build user interfaces capable of being shared with all audiences.

Qualifications

chemical / biochemical / biomedical engineering, computer science / programming, or mathematics / statistics.

Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

The headquarters in Basel is one of Roche’s largest sites, over 8,000 people from approximately 80 countries work at Roche Basel. Favored by its geographic location in the heart of Europe, the Basel area is one of the most dynamic economic regions in Switzerland – a great place to live and work.

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10,000 employees worldwide.

“Product & Supply Chain Management” (PTS) connects the different parts of Roche to ensure reliable supply of our innovative medicine to customers and patients.  The group ensures worldwide reliable supply to patients connecting their needs to the Roche Pharma Global Supply Network.  This network consists of Roche manufacturing sites, contract manufacturers and external suppliers.  Lastly, PTS leads Product Management Teams within PT, develops and implements product strategies as well as designs and optimizes full Supply Chains from raw materials to final product throughout the whole product life-cycle.

The Digital & Advanced Analytics Stream, has a key role defining Supply Chain and Tech Ops embark on a digital transformation journey. This is an innovative and fast-growing team to develop innovative solutions and state-of-the-art processes for our company in an environment where the worlds of business, creativity, and technology intersect.

Summary

This position is a key member of the Digital Incubator in Supply Chain, supporting its launch and contributing to all its activities. It will participate in the selection and structure around innovation initiatives from ideation to handoff (for execution), managing key interactions, timelines, and  reporting; he/she will take the responsibility to establish small teams experimenting  around specific initiatives and ideas.

He/She will have an active role in gathering and spreading knowledge around  Digital and Innovation topics in various forms across all the organization, fostering a mindset change towards Digital Innovation in all PTS functions.

The position

As part of the Digital Transformation Team, will support the conception and  implementation on next generation solutions to ensure adherence to broader enterprise technology strategy.

Will also support the execution of selected strategic initiatives, assessing the value creation and cost estimation, ensuring resources and connection within other areas and initiatives across PT.

The scope of accountabilities includes but is not limited to the following tasks and roles:

• Be a core team member of the Digital Incubator, participating in its initial setup and future daily activities.
• Collaborate in identifying, assessing and selecting innovative ideas from internal and external sources, based on their value proposition.
• Promote employee engagement through "intrapreneurship" & crowdsourcing by defining, activating and supporting innovation challenges  or hackathons across the company
• Collaborate in spreading knowledge and enhancement of the workforce capabilities.
• Bypass roadblocks created by standard Roche processes to effectively try new ideas and ways of working, through effective stakeholder management to deliver results in short periods of time
• Drive rapid design and development of minimum viable products, supporting future business models and innovation on personalized supply chain.
• Support scale up of successful ideas
• Coaching PTS members into the Lean Startup Agile methodology mindset
• Support the effort to build a collaboration network within Roche for Digital & Innovation related topics, ensuring regular exchange
• Act as a role model for Digital Innovation, Data Ownership and Value Creation within PTS, proactively coaching colleagues into the concepts

Who you are:

The ideal candidate is passionate about using data driven methods for solving complex problems. Interaction with subject matter experts and management to understand situations and develop solutions consistent with our business strategies is a critical component for success and has a proven track record of getting things done.

We look for people who are excited about solving business issues and making a lasting impact by transforming operations. Entrepreneurial Spirit. Must be outgoing and enthusiastic about new technologies and market opportunities.

You’re a person who is open to new ideas and challenge conventional paradigms. Define development opportunities and ensure feasibility analysis of potential initiatives.

In addition to these competencies, you provide a mix the following qualifications:

• BS/MS/Ph.D Degree in science, engineering, business, supply chain or equivalents.
• Preferably a minimum of 5 years experience in Supply Chain & Business related areas (Commercial, Planning, Logistics and, Manufacturing are appreciated)
• Technology and Data savviness, passionate about latest technology trends and data driven mindset, innovative and curious mindset, with a passion for learning and teaching
• Self driven and proactive, comfortable to deliver as a team leader, team member and individual contributor
• Ability to effectively communicate and influence others across ALL levels of the organization in order to drive transformational change
• Excellent at building and maintaining constructive and effective relationships with internal and external stakeholders
• Knowledge in big data, advanced analytics, business intelligence platforms and other high tech macro trends is highly valued.
• Financial and Business Acumen including business case development
• Knowledge of: SCRUM, Agile Methodologies, Change Management, Project Management.
• General understand Roche Operating Principles and business processes.
• Mobility: Ability to travel up to 30%

Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

The headquarters in Basel is one of Roche’s largest sites, over 8,000 people from approximately 80 countries work at Roche Basel. Favored by its geographic location in the heart of Europe, the Basel area is one of the most dynamic economic regions in Switzerland – a great place to live and work.

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10,000 employees worldwide.

“Product & Supply Chain Management” (PTS) connects the different parts of Roche to ensure reliable supply of our innovative medicine to customers and patients.  The group ensures worldwide reliable supply to patients connecting their needs to the Roche Pharma Global Supply Network.  This network consists of Roche manufacturing sites, contract manufacturers and external suppliers.  Lastly, PTS leads Product Management Teams within PT, develops and implements product strategies as well as designs and optimizes full Supply Chains from raw materials to final product throughout the whole product life-cycle.

The Digital & Advanced Analytics Stream, has a key role defining Supply Chain and Tech Ops embark on a digital transformation journey. This is an innovative and fast-growing team to develop innovative solutions and state-of-the-art processes for our company in an environment where the worlds of business, creativity, and technology intersect.

Summary

This position is a key member of the Digital Transformation in Global Pharma Supply Chain, supporting its launch and contributing to all its operations. The person will lead the activities related with Data and Analytics, coordinate external resources which will support different initiatives within the organization. The person will be the interface for Supply Chain in all Advanced Analytics towards other functions and organizations.

He/She will have an active role in gathering, fostering and spreading knowledge related with data and analytics across the entire organization, supporting a mindset change towards Digital Innovation in all Supply Chain functions and beyond.

The position

As part of the Digital Transformation team, he/she will support the conception and  implementation of the next generation solutions for Supply Chain that will adhere to a broader enterprise technology strategy.

As a key member he/she will support the execution phases of strategic initiatives, assess the value creation and cost estimation, ensure resources and synergise with other areas and initiatives across Technical Operations.

The scope of accountabilities includes but is not limited to the following tasks and roles:

• Identify and explore data and advanced analytics opportunities through collaboration with multiple corporate business units and external partners
• Leverage opportunities to apply advanced analytics techniques to internal and external data sources and provide innovative approaches to generate insights
• Provides recommendations about strategy, analysis methods, and tool selection to the Digital Incubator Initiative
• Support technical training of team members, suggesting best ways to increase data and technology acumen
• Promote the cultural & mindset shift towards Digital Innovation,  value creation and support the establishment of a Data Ownership Mindset
• Support the rapid design and development of minimum viable products of new employee generated Digital products, business models and innovation on personalized supply chains, providing guidance and input for the data and advanced analytics component
• Coordinate the external and internal work of ongoing initiatives in the area of data science including advanced analytics
• Acquire, lead, partner and manage internal/external resources that contribute  to the different Digital Incubator initiatives in the Data and Analytics

Who you are:

The ideal candidate is passionate about using data driven methods for solving complex problems. Interacts with subject matter experts and management to understand situations and develop solutions consistent with our business strategies is a critical component for success and has a proven track record of getting things done.

We are looking for people who are excited about solving business issues and making a lasting impact by transforming operations. Entrepreneurial Spirit. Must be outgoing and enthusiastic about new technologies and market opportunities.

You are a person who is open to new ideas and challenges conventional paradigms. Define development opportunities and ensure feasibility analysis of potential initiatives.

In addition to these competencies, you provide the following qualifications:

• BS/MS/Ph.D Degree in science, engineering, business, supply chain or equivalents
• Capacity to act as a translator between business and technical groups
• Display effective organization skills, managing multiple and competing priorities and coaching others to improve these skills
• Technology and Data savviness, connected to latest technology trends and data driven mindset
• Experience with SAS, R, Python, or Matlab is required. Hands-on analytical skills in predictive and prescriptive modeling, machine learning, data mining, time series forecasting and optimization algorithms
• Previous experience in a Data Science/Analytics role.
• Ability to effectively communicate and influence others across ALL levels of the organization in order to drive transformational change
• General understanding of Roche operating principles and business processes.
• Ability to foster innovation and generation of minimum viable products
• Intermediate Relational Database knowledge (normalization, optimization, etc.)
• Knowledge of non-relational databases
• Basic cloud computing/cloud services knowledge is valued.
• Strong analytical & process design skills
• Mobility: Ability to travel up to 20%

The Communication Operations Manager to the PHC 2.0 Center of Excellence (CoE) supports and reports to the Principal Communications Business Partner of the PHC 2.0 CoE. The Communications Operations Manager is responsible for managing the many workstreams for internal and external communications around the PHC 2.0 strategy within the Roche

Pharmaceuticals Division. The CoE is an essential part of the corporate-wide strategy to advance Personalized Healthcare into the digital era (“PHC 2.0”) and comprises a wide range of function representatives from across all aspects of the Pharmaceutical value chain. The role is based in South San Francisco to ensure proximity to the Head of PHC 2.0 Global

Product Strategy and the Head of PHC 2.0 Research & Development and their leadership teams, and will also work closely with functions based at Group headquarters in Basel, Switzerland.

Key Accountabilities

In this position, the individual will primarily be accountable for the following:

Cross group coordination and operational management of PHC 2.0 communications:

Serve as a primary, senior liaison between the CoE and other groups supporting the PHC 2.0 strategy (Group Communications, gRED, pRED, Medical Affairs, etc.)

Internal Communications:

Serve as a key member of the communications team supporting the PHC 2.0 Center of Excellence (CoE) within the Pharmaceutical Division (Global Product Strategy and Research &

Development), develop and execute activities and materials on internal communications strategy needs to assure success of and explain the CoE’s mission and PHC 2.0 strategy within

Roche’s Pharmaceuticals Division In close collaboration with Group Communications and GPS Communications, build and nurture internal engagement for the community around the CoE. context of Roche’s strategy personalized healthcare. More specifically: roll-out of CoE activities, materials such as messaging, presentations, etc. that inform on the CoE strategy’s impact for the Pharmaceuticals division.

Interface and Manage Agency Partners:

Roche engages an extensive network of agency partners to support its many communications needs. The expectation is the ideal candidate will have a keen understanding of how to build and maintain agency partners, how and when to activate agency resources

External Communications:

Counsel and advise on external communications and engagement opportunities and needs linked to the Pharma PHC 2.0 strategy in close collaboration with Group Comms, the group

wide PHC lead, public and employee comms, digital and media relations and GPS Communications Scout and supply relevant content (examples / proof points of current PHC activities) from within the CoE’s activities and remit for effective external corporate communications that bolster company reputation and support strategic stakeholder engagements

Functional:

Serve as custodian of the Roche-wide company brand standards within the CoE and ensure alignment to corporate messaging and storyline on advancing Personalized Healthcare in a

digital era.

Public & Employee Communications (PEC):

Work closely with the corporate content lead on PHC and Science Communications in Public and Employee Communications as a key contributor and interface alongside with business

partners from other functions (e.g. GPS Communications, Diagnostics, IT, Pharma Research & Early Development, etc.)

Key Experience Used in this Position

Working as part of a global, highly matrixed and decentralized team.

Key Functional Skills/Competencies Used in this Position

Demonstrated internal and external communications skills. Strong project management skills. Excellent oral/written skills. Strategic agility and multitasking. Ability to translate technical and complex concepts into plain language and engaging communications. Strong interpersonal and communication skills and the ability to interact with senior leaders and matrixed functions. Budget development and management

Example Responsibilities

Communications Business Operations:

Advise and counsel the Principal Communications Business Partner of the PHC 2.0 CoE to ensure clarity on short-, medium- and long-term communications needs both within the

Pharmaceuticals division and towards external stakeholders. Help to coordinate internal communications planning and execution for activities concerning positioning the CoE within the

rsus internal staff, and the agency budgeting process.

Interface to Corporate Communications Functions:

Serve as a content contributor to the Group-wide communications strategy on advancing

Personalized Healthcare in a digital era by identifying, preparing and supplying engaging content from within the CoE’s activities, e.g. storylines, hooks, interviews and other content

Work closely with GPS Communications and corporate functions such as Public and Employee Communications and Digital Communications to strengthen Group-wide editorial and content strategy and amplify external communications in accordance with business needs from the perspective of the CoE

Corporate Brand Custodianship:

Serve as custodian of the Roche-wide company brand standards within the CoE and its communications activities. Understand and apply the Roche Brand standards in visual, voice

and messaging. Weave in the corporate messaging and storyline on advancing Personalized Healthcare in a digital era to ensure one voice across the Roche Group within the Pharmaceuticals division.

Qualifications, Experience, Knowledge, Skills & Abilities

Candidates for this position should hold the following qualifications, experience, and be able to

demonstrate the following knowledge, skills and abilities to be considered as a suitable

applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed

below are considered minimum requirements.

Requirements and Qualifications

University Degree (BA, BS, etc. at a minimum). MS, MA, MBA or post graduate studies are preferred.

Global travel, primarily to Roche Headquarters in Basel, Switzerland. Roughly 15-20% travel, negotiable.

Experience

Minimum 15 years of experience in corporate communications, mix of agency and in-house preferred.

Communications experience a plus.

Experience in biotech and/or healthcare industries

Experience working within a matrix organization as well as in a multicultural environment

Demonstrable experience working in fast paced environments and adapting to changing stakeholder needs

Experience working on cross-functional projects and presenting to senior company executives/audiences Experience managing budget

Knowledge

Global business understanding, acumen and the knowledge of how to work in that structure.

Knowledge of organizational and people behavior.

Skills/Abilities

Extract & process key information / provide targeted insights & recommendations. Distill & interpret business strategy to drive engagement with key stakeholders Influencing and

negotiation skills, as well as interpersonal & partnering skills Proven track record of meeting or exceeding objectives and goals Can manage managers and senior leaders: can also ensure the accomplishment of goals and targets through indirect leadership.

Outstanding consulting skills: consistent and proven track record of helping internal partners/stakeholders address strategic opportunities and solve problems; strong facilitation skills Strong communication & presentation skills: consistently exhibits professional maturity, confidence and competence

Solid organizational & time management skills: proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion

Outstanding interpersonal & partnering skills: proven track record of building strong and sustainable relationships with internal and external partners/stakeholders

Ability to travel globally.

Fluent written and verbal English.

Genentech's Device Development group in South San Francisco is searching for an experienced Validation Engineer to join the team on a temporary basis. The role is responsible for providing development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at Genentech. The candidate should have technical expertise in development, qualification & validation, and maintenance of Laboratory Equipment, Test Methods, and Laboratory Computer Systems for instruments, and provides technical expertise to support engineering and scientific activities within Genentech’s device development programs.

RESPONSIBILITIES

The Validation Engineer will work collaboratively across functions (e.g. quality, IT, and vendors), assist Device Engineers and Laboratory staff in developing practical and thorough solutions to problems, and lead and execute validation activities: method validation, equipment qualification, computer system validation, and method transfer. This role will accomplish objectives by executing activities in the areas of:

Equipment Qualification and Computer Systems Validation

• Implement and coordinate commissioning and qualification of laboratory equipment and computer systems (e.g. hardware, software, and accessory systems) for use in regulated and non-regulated operations.
• Author commissioning and qualification of CSV documents through system life cycle. This includes deliverables such as user requirements, functional/design specifications, qualification protocols, reporting, and support documentation (i.e. traceability matrices, SOP, etc.).
• Review laboratory requirements and define procedures for instrument and data management/data integrity.
• Implement 21 CFR Part 11 for new and existing testing computerized laboratory instruments, perform gap assessments and define resolutions in compliance with cGMP requirements.
• Support installation activities when needed to ensure proper systems startup and recommend changes to improve system design.
• Regularly interact with external development partners and equipment suppliers, Quality, and IT group.

(Test) Method Validation

• Lead and execute test method validation and method transfer, and develop new test methods as required by projects.
• Apply Measurement System Analysis statistical approaches such as Gage R&R for validation of new methods.
• Perform First Article Inspection and design fixtures as needed.
• Author, review and/or approve validation documents to support device development deliverables such as protocols and report, test methods, and risk assessments.

General

• Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
• Use (and create and implement, if necessary) local procedures and templates ensuring alignment with current versions of PQS documents and best practices.
• Support the laboratory lead in preparing communications for internal review committees.
• Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
• Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
• Ensure compliance of training to PQS and job-related requirements.
• Utilize electronic document archive system and collaborate with Records Management team to ensure document compliance with PQS standards and DHF regulations.
• Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.

QUALIFICATIONS

• B.S, M.S, or Ph.D in Science or Engineering.
• 5+ years of industry experience.
• Strong knowledge of FDA regulations and experience in implementing 21 CFR Part 11.
• Knowledge of CSV requirements and procedures for laboratory instrumentation and instrument qualification (IQ/OQ/PQ).
• Knowledge of Measurement System Analysis (MSA) and statistical analysis.
• Working knowledge of the development of protocols for the validation of complex computer systems (e.g., multiple GAMP classes of systems).
• Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, etc..
• Six Sigma (Green/Black Belt): DMAIC and DFSS.
• Excellent oral and written communication skills.
• Ability to work in a team, highly organized, and detail oriented.

This is a temporary assignment. The individual in this role will be employed by a third party, not by Genentech.