As the Medical Director you willbe responsible for the design, implementation, monitoring, analysis, andreporting of studies conducted within the Late Development Oncologyorganization. You will also participate in developing the long-range strategicplans for the molecule or molecules within the area of Oncology.

Key Accountabilities:

Assisting in the overall management,planning, evaluation and documentation of projects and studies

Participation in on-going medicinedevelopment activities including:

•  Preparation of regulatory documentsand interaction with global regulatory authorities

•  Monitoring and reviewing incomingdata

•  Analysis, presentation andinterpenetration of on-going studies and published data

•  Interactions with health authoritiesand expert bodies

•  Close collaboration with drugsafety, regulatory affairs, medical affairs and clinical trial operations

•  Participation in the preparation ofabstracts, posters and presentations for scientific meetings and congresses

•  Developing and writing clinical plansand protocols ensuring that they are scientifically sound

To be successful in this role, youwill have the following skills and experience:

•  Solid experience in medical research includingwriting clinical study reports and interpreting clinical data

•  Good communication and collaborativeskills with experience at working with cross-functional and external groups,including researchers, clinicians and other stakeholders.

•  Proven track record of delivery ofexperimental or novel studies

Confidence at presenting at internaland external strategy meetings

The Senior/Principal Health Economist is part of the broader Oncology Medical Unit organization and provides health economics and outcomes research, modeling, reporting, and other relevant analyses, within applicable legal and regulatory guidelines, which can be used to quantify the value of Genentech products in economic or societal terms. 

The Senior/Principal Health Economist will work with multiple products and indications within the Oncology portfolio and will support cross-functional Genentech and Roche teams by recommending, developing/conducting and advising on HEOR research and modeling strategies, and by developing medical and payer value propositions, portions of product dossiers, and other scientifically-based communications. 

This team supports strategic decision-making for late-stage development and across the product lifecycle. The Senior/Principal Health Economist helps set Genentech HEOR strategies, direction, objectives, and plans for innovative, effective and efficient execution. 

The Senior/Principal Health Economist will be fully accountable for compliance with all laws, regulations and policies that govern the conduct of Genentech activities. As a manager and coach of others, the AD/PHE is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, s/he leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. The Senior/Principal Health Economist monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required. ¿

Responsibilities:

Incumbents are generally expected to:

• Functional lead for HEOR activities for the molecules and indications assigned, including participation in design and conduct of studies as needed

• Set and manage to outside spend budgets for multiple projects and products, including assuring that direct reports meet budget commitments and develop financial management skills

• Manage one or more health economists or other HEOR staff, with less than half of his/her time devoted to management

• Including hiring, development and ensuring technical excellence

• Directly engaged in designing, developing and conducting HEOR studies with strategic impact for the molecules for which she/he is responsible

• Maintain strong, positive relationships with senior internal stakeholders across Genentech and Roche 

• Lead development of the vision, strategic and tactical plans, resource and budget plans, for the products and indications under his/her responsibility.  Includes establishing annual and longer-range plans, goals and objectives, and effectively aligning these with Genentech and Roche cross-functional research, development and commercial strategies and objectives.

• Lead and manage execution to ensure work is completed on-time, on-target and within-budget, with the highest levels of accuracy and relevance, and in consistent compliance with legal and regulatory guidelines, Genentech and Roche policies & procedures:

• Working collaboratively, effectively and efficiently with all internal and external customers, partners, stakeholders and influencers

• Develop and cultivate relationships with key KOLs (Key Opinion Leaders) and other thought leaders, to support HEOR strategies, plans and objectives and provide strategic, critical influence for Genentech's product pipeline and portfolio

• Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies.

• Utilize only approved resources and messages to meet goals and targets

This position is for a Principal Engineer/Principal Manufacturing Technical Specialist reporting to the Associate Director of Technology Validation in the South San Francisco Production Technology Department.  The candidate will independently lead highly complex compliance and transformational validation program projects.  The candidate will also be expected to lead site implementation of complex multi-site CAPAs and quality system deployments.  These projects require close collaboration with site Manufacturing, MSAT and Quality and other functions as well as network colleagues and corporate quality functions over the course of multiple years.  This candidate will sit on the Technology Validation Leadership Team and will assist the Associate Director in developing group goals and development plans.  The candidate must provide mentorship and direction to staff on interpretation of the Roche Quality System requirements, execution of the Qualification Lifecycle and Qualification Strategies for highly complex projects.  This candidate will also be responsible for representing Genentech in agency inspections and audits.  They will participate in network teams developing quality system approaches.

The PD Biometrics and Clinical Sciences Informatics (FPPO) team is looking for a highly skilled Delivery Service Manager, who will support the Biostatistics, EpiPRO, and Thesaurus Management systems area.  This candidate will be able to deal with a diverse and multicultural, global team in varied time zones, who is proactive, outgoing and detail- oriented with excellent problem solving, and written/verbal communication skills. 

Further responsibilities are:

• Applies complex procedures and defined standards to meet current business, customer and technical requirements and leads others in resolution of complex problems.
• Leads specialist resources on technical issues within the domain on content and provides detailed analysis of the operations and opportunities for improvement.
• Develops business/technical critical know-how within area of expertise for the function and is familiar with opinion leaders in the field. Assists in the development of others know-how by passing on knowledge of tools and techniques.
• Supports day to day operations and / or implementation of projects within area of technical expertise, contributes to the implementation planning and may execute some aspects of that plan. Accountable for roll-out of new services or enhancement to existing services.
• Manages incident and problem management processes, release and configuration management according to ITIL. This includes continuous improvement for the management of the services. Acts as the initial point of escalation for incident, problem and change management for the Business Representative (e.g. Business Lead)
• Administers change control procedure and processes. This includes the management of the change control board and oversight of the approved change 
• Is well-versed in vendor management and can look for new opportunities to optimize our vendor contracts and relationships.
• Is familiar with Statement of Work (SOW) and procurement processes
• Is customer-focused and able to track problems/issues to their resolution with the appropriate level of follow-up to the user community
• Builds and maintains good working relationships with the Business Representative and the client business base , monitors services and providing regular service reports to the FPPO management and business clients

• Provide business and project management support across a broad range of projects in Medical Affairs with primary focus on providing support to the Field Medical Teams (FMT)
• Build and manage the FMT Strategic and Operational Plan, working with key internal stakeholders to enable effective evaluation of current gaps, future needs, prioritization and resource alignment/allocation
• Perform project budget and work plan reviews, project alignment and prioritization activities and resource utilization analyses
• Partner with IT function and/or work with project sponsor and stakeholders to complete project charter outlining scope, goals, deliverables, required resources, budget and timing
• Responsible for driving and delivering the project on-time & within budget and meeting the strategic business needs through effective project management methodology/principles
• Manage project scope, resources and stakeholders expectations/requirements
• Develop systematic approach, ongoing improvements and innovations to enhance performance in problem solving and project management
• Build coalitions among the various stakeholders and negotiate authority to move projects forward
• Proactively engage stakeholders throughout the project to gain their commitment, agreement and support on the proposed solutions, priority setting and implementation
• Consult and provide advice; facilitate discussion and resolve conflict; establish trust, build and use cross functional relationships to accomplish work objectives
• Advocate on behalf of stakeholders to negotiate with service provider (e.g. vendor and/or IT function) to ensure proper solutions meet the business strategic objectives
• Facilitate and lead all aspects of organizational changes for the assigned project responsibilities
• Communicate and/or present project timeline, risks, and overall status to the business functional leaders, senior managers, all appropriate stakeholders, and project team members
• Establish timely and proper communications to business sponsor and stakeholders that includes centralizing projects activities & information via dashboard or other mechanism
• Make decisions and take timely independent action in pursuit of priorities

Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Program Directors are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Associate Program Directors provide regulatory leadership for one or more regional development projects. Regulatory Program Management Associate Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Regulatory Program Management Associate Program Directors are expected to lead their assigned projects and represent PDR to cross-functional teams and groups with supervision. Regulatory Program Management Associate Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners. Regulatory Program Management Associate Program Directors serve as the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.

EXAMPLE DUTIES AND RESPONSIBILITIES:

Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate

Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices

Provides regulatory expertise and leadership to site and regional cross-functional teams and other groups

Stays abreast of therapeutic area product development and other related business strategies and plans 

Serves as the primary PDR representative on one or more regional projects at any one point in time

Analyzes data, the regulatory environment and business objectives to recommend priorities

Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment.  Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche

Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development

Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment

Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project

Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management

Serves as the site and/or regional principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site and/or regional teams

Provides internal teams with direction on regulatory authority interactions

Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters.  Manages RAFT resources

Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made

Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary 

Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions ...

Senior Business Systems Analyst 

The Senior Business Systems Analyst will be responsible for supporting Strategic Pricing and Contracting Management (SPCM) systems planning and business process support, including contract development, contract administration and government price reporting operations. This role supports alignment of business processes and systems to provide accurate business monitoring, analytics and operational excellence across SPCM Teams.

The Senior Business Systems Analyst will be responsible for providing leadership on system projects including data analysis, user requirement gathering and documentation, business process documentation, and impact and gap analysis. They will serve as the subject matter expert for contract development, contract administration and government price reporting business processes, and the Veritas applications.

The Senior Business Systems Analyst will need to develop an understanding of the complex data environment in order to enhance standard reports, perform analysis and develop ad hoc queries and reports. This position requires the ability to retrieve data from multiple environments, identify trends, perform analysis and make recommendations. They may also lead or participate in developing data management strategies (including MCCO IT initiatives such as with the Channel, Customer and Contracting Performance, C3PI Initiative) and implementing accurate infrastructure for robust and hight-accuracy analytics. The position also requires strong written and verbal communication skills and an ability to collaborate with management and other functional groups within the Commercial organization. The data analysis will also support the SPCM Operational Excellence program that will be driven by existing and new metrics.

This position will be expected to have an up-to-date knowledge of the enterprise IT strategic direction and be able to influence IT system decisions that will be cost-effective, supportable and scalable. This will require strong leadership on projects and in the prioritization of the overall project portfolio, developing business cases and driving to maximize sIT ROI. This position reports to the Group Manager, Strategic Pricing and Contract Process and Technology.

Dept: Biological Assays, Method Management and Technology, PTQBP

Job Category: Quality
Location: SSF

Department: MMTech (Method Management and Technology)
Description: Senior Scientist Bioassay

Summary

The Biological Assay Function within Genentech’s Global Quality Organization is responsible for life-cycle management and innovation of post-BLA biological potency methods and specifications. We serve as the scientific and technical Center of Excellence for biological assays and analytical ELISAs within Commercial Quality for the Roche/Genentech Global Quality Network. We are looking for an experienced Senior Scientist to take on a leadership role and to play an integral part in the function.

 
Requirements

Candidates must have in-depth experience in the development of cell-based potency assays and immunoassays in an industrial setting. Understanding of mechanism-of-action of antibody-based protein therapeutics is essential. Broad experience with a variety of biological in-vitro systems is required. Familiarity with antibody effector function determination and enzymatic assays would be an asset. Prior experience in assay validation/ qualification and technology transfer are highly desirable, as is GMP experience and a strong sense for compliance. Familiarity with common applications analyzing the dose-response relationship will be very helpful (SoftMaxPro, XLFit, PLA etc). Working knowledge of statistical approaches will be helpful. Must be highly motivated and comfortable working independently in a fast-paced environment. Experience with regulatory submissions (IND/BLA) and Health Authority interactions will be advantageous. Management experience of direct reports is expected.

The Records and Technology Manager will focus on electronic records management.  The purpose of this position is to supplement the Corporate Records department at Genentech that develops policy and consults on information issues, provides some operational support, and develops and delivers training on records management topics.  We expect close collaboration with the Genentech team, and with Roche global partners and stakeholders.

The Records and Technology manager will be responsible for developing strategies to apply records management principles to both structured and unstructured electronically stored information throughout its lifecycle.  The candidate needs to be knowledgeable about records management principles and have a deep understanding of systems that enable people to create, use, find, and share information such as document management systems, databases, collaboration applications, archive platforms, email systems, and cloud computing.  The candidate will be knowledgeable about emerging technologies and be able to identify records management concerns.  Some timely topics include system decommissions, email management, retention and lifecycle management of data in collaborative systems, application of retention periods to electronic records, and recommended formats and other issues related to long term preservation of electronic records.  The candidate who assumes this role will also oversee the staff managing the offsite storage services and application. 

Job Purpose:

The IT Business Systems Analyst (BSA) position in the Patient & Physician Solutions team will be responsible for the delivery of technology capabilities for the Access Solutions organization in the US, which provides services to help people access Genentech medicines for a range serious conditions. The IT BSA will work on multiple projects for both internally-facing case management tools and externally facing web-based solutions serving physicians and patients, and will be accountable for understanding the needs of customers, developing effective user-friendly designs to meet those needs, and delivering detailed requirements and specifications to drive the development, testing, deployment and production support of IT systems.  

Primary Responsibilities:

The IT Business System Analyst (BSA) will drive the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology, which can follow either a traditional “waterfall” path or an “agile” path.   The IT BSA will assist in determining which methodology path will be most likely to ensure a successful delivery.  The BSA will be responsible for building deep understanding of processes used by medical practices and internal case managers to serve patients, and for integrating the knowledge into the design and delivery of tools to serve all users.  The IT BSA will establish themselves as a “thought partner” with internal customers.   The IT BSA will assure smooth integration with key partners leading the development, testing, training, communication and deployment of technology across the country, keeping management apprised of developments through clear and timely communication.  

Specific responsibilities include: 

• Collaborate with Project Managers, Architects, Engineers, Developers, User Experience Designers and Software Quality Assurance on scope, solutions, constraints, and risks 
• Analyze/document current and future business process models 
• Analyze/document high-level requirements (scope) 
• Analyze/document detailed functional requirements and business rules (use cases) 
• Analyze/document data requirements (from business needs perspective) 
• Support planning of user acceptance test (UAT), including creation of UAT scripts 
• Perform knowledge transfer to training and communication teams and support user deployment activities as needed
• Lead business stakeholders and other business systems analysts thru the business analysis lifecycle

The candidate will be a member of the Analytical Chemistry group in the Method Management and Technology (MMTech) Function within Genentech’s Corporate Quality Organization.  MMTech is the scientific and technical Center of Excellence for commercial quality control methods, specifications/control systems and reference standard and provides support to the Roche/Genentech Global Quality Control Network for the commercial biotech product portfolio. We are looking for an experienced Scientist to play an integral part in providing and supporting analytical chemistry methods (e.g. HPLC, CE) used for quality control purposes.

MAIN PURPOSE OF THE POSITION

• Responsible for method troubleshooting and optimization in support of life-cycle management of methods for Roche/Genentech commercial biotech products
• Develop and execute experiments for the development, validation, implementation of QC test methods for commercial biologic products following cGMP regulations, regulatory guidelines as well as local and global quality standards.
• Support regulatory submission and inspections: through authorship of CMC subsections, responses to questions and direct interactions

JOB DUTIES/RESPONSIBILITIES

• Serve as analytical technical lead/representative (biotech products) on cross-functional and multi-site project teams.
• Ensure on-time delivery of controlled documents, reports and method packages to support project timelines.
• Apply technical knowledge, scientific experience and expert judgment to address a broad range of difficult problems.
• Troubleshoot and direct the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of departmental functions.
• Perform assigned tasks and work to achieve company goals and department objectives.
• Train personnel and internal customers on relevant business processes.
• Support the development and administration of Quality Control and laboratory training materials.

A post-doctoral research fellow position isavailable in the Late Stage Pharmaceutical Development group to investigate thetemperature and concentration dependence of protein interactions in solutionand cryogenic conditions. Many monoclonal antibody (MAb) products are developedas high concentration solutions, and have been observed to present a range ofissues (aggregation, precipitation, phase separation) on storage. Thetemperature dependence of intermolecular interactions between proteins andother solution components remains poorly understood, in particular in cyro-concentratedconditions. The objective of the post-doctoral research fellow will be to characterizethe temperature dependent interactions of antibodies in both liquid and frozen glassystates, using a variety of biophysical techniques and novel experimentalapproaches to gain understanding of the underlying molecular basis of theprotein and solvent interactions that result in a variety of bulk solutionbehaviors.

• The successful candidatewill be responsible for the design, development and implementation of delivery devicesfor parenteral pharmaceutical therapeutics.  Primary technologies in-scope of the role includemanual injection systems, automated injection systems, and interfaces withpre-filled syringes and cartridges.
• Major responsibilitieswill include the development and commercialization of devices includinginterfaces with the primary container.
• This person will be atechnical expert and will provide technical leadership in the development andcommercialization of new drug-device combination products in collaboration withRoche and Genentech's engineering, scientific, and manufacturing organizations.
• He/she will provideguidance and input regarding product development and will regularly interfacewith staff and leaders in Commercial Marketing, Clinical Sciences, ContractManufacturing, Product Core Teams, Pharmaceutical Development, PackagingDevelopment, Quality and Regulatory Affairs.
• He/she will also regularlyinteract with external development partners and component suppliers, and may alsosupervise staff members.

Sr. Product Manager

 Senior Product Managers in Managed Care Marketing develop, implement and manage the managed care marketing strategy, plan and tactics. Managed Care Marketing directly supports Genentech’s business by ensuring managed care marketing strategies, plans and tactics enable business, financial and operational goals, targets and objectives to be met or exceeded across managed care segments within the U.S. Senior Product Managers act as a primary liaison to managed care account management and may also have matrix responsibilities to represent Managed Care Marketing for one or more products or franchises, as assigned.

•  Stays abreast of and continuously develops his/her knowledge regarding internal and external business developments and drivers. Includes in-depth knowledge of the current and evolving managed care landscape and its implications for Genentech -  formulary positioning, reimbursement, access and overall market share

• Responsible for educating internal partners and stakeholders regarding the managed care landscape in the U.S. and related territories and implications of such to current, medium- and longer-term managed care marketing strategies, plans and objectives

• Reviews and assesses cross-functional business strategies, plans and tactics; using to determine and recommend managed care marketing strategies, plans and activities that support optimal formulary  positioning, reimbursement, access and overall market share

• Contributes new creative, innovative opportunities; increasing adoption, pull-through and overall financial results

• Develops the Value-based Healthcare (VBH) strategy and tactics; including driving and shaping key customer partner initiatives in oncology

• Works closely with cross-functional teams to align therapeutic area and managed care marketing strategies, plans and tactics with pricing, reimbursement, contracting, distribution and other relevant business, financial and operational strategies, plans and objectives 

• Contributes expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans

• Conducts field visits with key customers to review Genentech’s breadth of offerings

• Develops key VBH resources for MCCO (Managed Care & Customer Operations) field, collecting customer insights, creating tactics for case managers and training MCCO on resources

• Where applicable, supports product launches. May participate in the development and implementation of managed care marketing launch plans. Includes contributing managed care marketing expertise to other aspects of the overall launch plan and helping ensure launch plan excellence

• Works with cross-functional groups to ensure a seamless and well-integrated message and overall positioning across multiple marketing platforms, e.g., online, direct-to-patient, etc.

• Provides strategic consultation to brands and MCCO groups regarding key brand market events

• Creates appropriate marketing budgets by working with peers, manager and/or other internal partners

• Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility

• Continuously monitors and measures effectiveness and results from managed care marketing strategies, plans and objectives. Regularly reviews forecasting and other business analyses and uses to make appropriate further recommendations to increase market access, address currently unmet needs, and generally help to improve the overall market strength for Genentech in assigned managed care segments

• Directly manages the implementation of all assigned managed care marketing plans and tactics to ensure timely and quality execution that will meet or exceed assigned targets, goals and objectives

• Works with others to identify, recommend, create and help implement new account management tools/resources that will enable the field to represent Genentech in accordance with the defined strategy and position
  Complies with all laws, regulations and policies that govern the conduct of GNE activities
  

Purpose:
• Solve a wide range of difficult validation activities and quality issues that impact multiple functions following cGMP regulations and company standards.
• Identify gaps and declining trends as well as innovate on processes and tools to simplify work and standardize practices.
• Build relationships and teamwork across departments, functions, and organizations to ensure commitment and adherence to PTQ strategies and initiatives.
• Be open-minded to diversity in people and ideas and be customer focused without sacrificing quality.
• Perform assigned tasks and work to achieve company goals and department objectives.

Accountabilities:
• Innovate and develop tools and processes to improve standard work and efficiencies.
• Build relationships to influence and dissimulate PTQ strategies, processes, and initiatives.
• Proactively identify gaps and trends in quality and compliance in order to proactive prevent decrease in compliance for inspections.
• Be open to diverse opinions, ideas, and viewpoints to be in a position to make the best decisions, plan, and executions.
• Balance between customer service and compliance without sacrificing quality standards and quality of work.
• Establish and follow company policies and procedures.
• Maintain a state of inspection readiness.
• Provide input to the development of personal performance goals and departmental objectives.
• Establish work priorities to meet targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned resources when applicable.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Development and manage department and cross-functional initiatives.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Develop and train personnel and internal customers on relevant business processes.
• Mentor junior personnel serving as a subject matter expert (SME) on quality systems, processes and issues.
• Collaborate on and author department policies or guidelines.
• Make decisions that impact the goals and objectives of the department.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Be accountable for behaviors as described in companies Core, Common, and Critical Competencies.
• Perform any other tasks as requested by Management to support quality oversight activities

Requirements:
• Process Chance Requests related to accountable computer systems.
• Determine Change level per quality policies and appropriate training.
• Review, assess and approve IT related changes.
• Collaborate with departments to ensure validation activities are executed efficiently and effectively.
• Provide guidance to internal and external customers on best practices for executing and maintaining a validation program.
• Develop strategies for new validation projects in collaboration with system owners.
• Develop near-term and long-range plans for the group in collaboration with Management.
• Review and approve applicable validation deliverables.
• Collaborate with departments to ensure validation activities are executed efficiently and effectively.
• Present and provide rationale for the validation strategies during internal and external audits.
• Ensure the department is represented on relevant project teams.
• Identify, design, and implement validation process improvements.
• Support internal and external audits.
• Assist senior personnel in support of regulatory inspections
• B.A. or B.S degree (preferably in Life Science or Engineering) and at least ten years experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience
• Sound knowledge of cGMPs or equivalent regulations
• Ability to interpret and relate quality Standards for implementation and review
• Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
• Ability to communicate clearly and professionally both in writing and verbally
• Flexibility in problem solving, providing direction and work hours to meet business...

This position  may be filled at a Strategy Manager or Sr. Strategy Manager level. 
 

The Strategy Manager is responsible for maximizing the value of Genentech's portfolio through the development of integrated pricing and contracting strategies for a specific therapeutic area or product(s). The role involves leading cross-functional strategy development teams, building effective relationships across all GNE franchises, scenario analysis/modeling for overall financial and legal viability, as well as ongoing contract performance assessment/analysis. Position involves extensive cross-functional collaboration with brand teams, Market Planning, MCCO Account Managers, Government Affairs, Health Economics and Global Pricing and Payer Planning.

• Conducting detailed analysis and constructing presentations to support recommendations to senior management on specific pricing actions for new and in-line products.
• Provides a leadership perspective on GNE pipeline pricing assessments for inclusion into payer planning activities, revenue forecast development, and decision-making.
• Works with internal/external partners/stakeholders to conduct regular market research
• Evaluating macro-trends in the healthcare environment that could potentially impact pricing and contracting opportunities and/or risks
• Provides business partners/stakeholders with in-depth analyses, modeling and optimal scenarios needed to determine the best contracting strategies to meet GNE objectives
• Works closely with partners in field Account Management to understand payer/channel customer needs, expectations, challenges, etc.
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

Genentech is seeking an Assistant/Associate Medical Director to participate in the development and execution of the clinical initiatives within the clinical ophthalmology group at Genentech. The Assistant/Associate Medical Director will be a key contributor in building an integrated development plan late development, will provide support to new development activities for Lucentis, as well as clinical guidance and assessment of future opportunities to advance the science and address unmet needs in ophthalmology.

RESPONSIBILITIES:

-Trial design, protocol development, and execution (Phase II-IIIb)
-Development assessments of clinical programs to support life-cycle
plan and new therapeutic initiatives with a focus on biologics and
ophthalmology.
-Clinical lead on implementation teams- -providing subject matter
expertise, clinical science support and functional representation
-Interact with the FDA, corporate partners and cross-functionally
across Genentech
-Build relationships and scientific outreach within the ophthalmology/retina specialty community
-Participate in cross-functional teams for the evaluation of new
development ideas, franchise medical strategies and business development assessments.
-Contribute to authorship and review process for scientific
publications and presentations.
-Assist with advisory board activities.

The Position

The IT Project Management position in the Patient & Physician Solutions team will be responsible for leading the delivery of technology projects in support of the Access Solutions in the US, which provides services to help people get access to Genentech medicines for a range of serious conditions.  The IT Project Manager is accountable for the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology, which can follow either a traditional “waterfall” path or an “agile” path. The IT Project Manager will be responsible for supervising work by the assigned resources, effectively tracking budgets and financial forecasts, creating and tracking detailed project plans, effectively leading and facilitating project meetings as well as proactively controlling project scope, risks and issues. This position is expected to provide timely status reports to all stakeholders and escalate issues to the appropriate management level. The IT Project Manager will be accountable for projects in the Patient and Physician portfolio, either through direct management of projects or by sourcing and overseeing contract Project Managers.

Primary Responsibilities:

• Define, plan, and direct the execution of technical projects, balancing the competing demands of scope, time, cost, quality, resources, and risk
• Identify, acquire, and lead multifunctional project teams
• Manage multiple projects, in addition to individual projects assigned to the position
• Ensure project objectives/requirements are clear and agreed to by all stakeholders
• Manage relationships with various technology and business communities to achieve project objectives
• Facilitate project management activities across the entire project management methodology
• Establishes and maintains effective communication for assigned projects and with dependent projects
• Ensure successful and timely completion of deliverables
• Track progress against baseline schedule
• Plan, baseline and control costs to ensure projects are completed within approved budget
• Identify and apply systematic quality activities to ensure that projects employ all processes needed to meet relevant Computer System Validation directives
• Suggest improvements where necessary / appropriate to improve operational efficiencies
• Conduct risk management planning, identification, analysis and monitoring on projects
• Formulate risk mitigation strategies and recommend solutions
• Manage the processes required to ensure timely and appropriate generation, collection, distribution, storage, retrieval, and ultimate disposition of project information and documentation necessary for successful communications across all stakeholders and any required updates to living system documents for validated systems
• Assign and supervise project activities to the team leads and team members.  Communicate and coordinate assignment and resource-related issues to Genentech management and resource vendor representatives.
• Other duties as assigned