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 Program Directors provide regulatory leadership for one or more regional or global development projects. Regulatory Program Management Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Program Directors are expected to lead more complex projects and represent PDR to cross-functional teams and groups with increased independence. Regulatory Program Management Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners.  Regulatory Program Management 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.

DUTIES & 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, regional or global 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 or global projects at any one point in time; typically complex projects
• 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, regional or global 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, regional and/or global 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 and other relevant regulatory documentation
• Responsible to ensure all PDR deliverables associated with each project or other assignment are completed within defined timelines and meet...

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

Lifecycle management of Enterprise Directory systems (Microsoft, SUN, Kerberos, Radiant Logic VD)

Lifecycle management of Federation systems (Ping Federate, Siteminder, Microsoft ADFS)

Work on projects related with these components

Create and manage Single Sign On integrations (Ping, Siteminder, JBoss)

Support other Identity and Access Management teams: Identity Systems, Access management, on/off boarding (worldwide presence)

Participate in security hardening drills, audits, proof of concept

Work on user requests, incidents and problems

• 2-7 years of successful technical experience supporting Enterprise Directories, Single Sign-On solutions and Federation Services for internal and hosted/SaaS applications
• Proven technical operational skills, and capability to create and validate well-structured answers and solutions in area of responsibility
• Proven interpersonal skills to interact effectively with Informatics staff in multiple countries and varying cultures
• Good understanding of Identity and Access Management systems, operations and related processes with focus on Active Directory, Federation Services, Kerberos, SUN LDAP and Password Management solutions.
• Provides 2nd level support related to Enterprise Directories, Single Sign-On and Federation Services.
• Documents the corresponding processes and components/solutions
•  

Problem Management

• Follows ITSM processes for 1st level problem management
• Act 
• s a source for establishing and recommending that multiple incidents should be declared as a problem to the relevant service providers. Tracks problems until resolved.
• Ensures accurate and complete problem tickets logged in ITSM tool adhering to Roche ITSM processes
• Ensures the Knowledge Management System (KMS) is updated with workarounds, known errors and solutions

Incident Management

• Follows ITSM processes for handling incidents
• Monitors ticket queues for the relevant workgroup action within agreed targets
• Ensures accurate and complete incident and change tickets are logged in ITSM tool and adhere to Roche ITSM processes
• Manages, meets and maintains service levels where appropriate
• Continuously improves own skills and knowledge base of services provided by Roche

• Plan and execute stress, performance and functional Test on applications and systems using automation and manual Testing. 
• Maintain an understanding of leading tools and technologies for development of mission critical web, database and related applications. (HP Suite, Selenium, Segue, etc). 
• Lead the development of SQA Test Plans, Specifications and Project Scheduling. 
• Collaborate with other SQA Leads in the development of  QA/QCProcedures, Test Scripts, and SQA lab standards and tools requirements. 
• Identify opportunities for process improvements that streamline development activities while minimizing risk.
• Mentor other team members in testing processes & testing tools in order to execute Test Plans as required
• Manage onsite and offshore testers

Group Strategy Manager 

 
The  purpose of the Group Manager, Strategic Pricing & Contracting role is to oversee and/or develop pricing and contract strategies for the assigned therapeutic areas and/or customer segments that optimize the value of Genentech's portfolio, which includes leading cross-functional strategy development teams, building effective relationships across all franchises relevant to the assigned therapeutic areas and/or customer segments and scenario analysis/modeling for overall financial and legal viability, as well as ongoing pricing and contract performance assessment/analysis.

1. Act as a lead subject matter expert from Strategic Pricing & Contracting
2. Play the lead role in cross-franchise assessment and integration of pricing and contracting strategies, plans and tactics; includes providing a leadership perspective and strategic pricing and contracting inputs into all business plans relevant to the assigned therapeutic areas and/or customer segments
3. Provide a leadership perspective on Genentech pipeline developments, as these relate to pricing and contracting strategies development and strategic options
4. Work effectively with Genentech executives to transfer and leverage learning across brands
5. Act as the lead contact on all internal and external communication regarding pricing and contracting strategies, philosophies and practices for the assigned therapeutic areas and/or customer segments; includes responding to internal/external inquiries regarding Genentech's pricing and contracting philosophies and practices
6. Develop internal/external reports, presentations and training to educate others in Genentech's pricing and contracting philosophies and practices
7. Take a leadership role in training other team members and internal partners/stakeholders in pricing and negotiating theory/application
8. Support manager in longer-range departmental planning; determining resource requirements, headcount, infrastructure, systems, tools and the like
9. Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies

QC Associate I (N5):

This is an 18 Month Term position on the weekend shift.

Main Purpose of the Position:     Perform analytical, biochemical, and/or biological testing; data review; and/or related activities that support QC operations. 

Job Duties/Responsibilities:

• Perform a broad variety of basic and moderately complex tests with documentation according to GMP Review data and assess against established acceptance criteria and peer generated data for basic methods.
• Prepare data tables and graphs
• Identify discrepancies andparticipate in quality investigations as needed.
• Receive and provide basic training
• Participate in assay transfer and assay validation.
• Perform testing for equipment qualification / maintenance
• Prepare and maintain standards, controls, stocks, and cultures per established procedures.
• Support the maintenance and compliance of operational areas.
• Assure and apply GMP throughout operations.
• Coordinate with customers to support operational activities.
• Support internal and external audits.
• Work to meet schedules.
• Identify and support resolution of technical problems.
• Actively participate in group and project teamwork; project and process improvements
• Drafts protocols and reports.
• Meets scheduled performance of 95% on time.
• Perform other duties as requested by managers to support Quality activities.
• Works under general supervision.
• Manager provides work priorities, timelines and resources
• Instructions given on new lines of work or special assignments.
• Progress on work assignments is generally reviewed on a regular basis.

Capabilities Identified for Success:

• Accountability
• Attention to Detail
• Communication
• Organization and Prioritization
• Policies, Process, Procedures
• Teamwork

SHE requirements

Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds…

The Informaticsteam is looking for a highly skilled Operations Lead, who will support the systemsthat enable the Sales & Marketing business teams.  In this role you will work closely with thebusiness leads, end user community, development teams, vendors and serviceproviders to provide the overall IT service. As service lead, the individual may also play other roles as requiredlike project manager and business analyst to ensure optimal service delivery.  This candidate will be proactive, outgoing and detail-orientedwith excellent problem solving and written/verbal communication skills.  The Operations Lead will have excellentcustomer relationship management skills with a service minded attitude and abilityto translate informatics terminology into business relevant language

Further responsibilities are:

• Supports day-to-day operations and / or implementation of projects within area of technical expertise, contributes to and executes implementation plans
• Manages incident and problem management processes as well as release and configuration management.  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 leads
• Administers change control procedure and processes. This includes the management of the change control board and oversight of approved changes
• Is well versed in vendor management and can look for new opportunities to optimize our vendor contracts and relationships
• Applies complex procedures and defined standards to meet business, customer and technical requirements and leads others in resolution of complex problems
• Leads specialist resources on technical issues within the domain and provides detailed analysis of the operations and opportunities for improvement
• Develops business/technical critical know-how within area of expertise.  Assists in the development of others know-how by passing on knowledge of tools and techniques
• Accountable for rollout of new services and enhancements to existing services
• Familiar with Statement of Work (SOW) and procurement processes
• Tracks problems/issues to resolution with the appropriate level of follow-up with the user community
• Participate in project teams to help identify solutions and requirements for new functionalities and performing impact analysis
• Builds and maintains good working relationships with the business leads and the user base, monitors services and provides regular service reports to Informatics and business leads

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

• Manage Quality system for change control and document management functions for GMP changes involving equipment, documents, test methods, processes and specifications for IMP Small Molecule and Biologics operations.
• Manage workflow through Trackwise and EDMS to ensure timely release of systems and documents.
• Proactively identify, prioritize and assess quality systems compliance risks across the IMP network
• Manage Quality System for discrepancy and CAPA management for IMP customers.
• Perform routine Quality trend analysis of IMP discrepancies and audit of incident discrepancies.
• Manage workflow through Trackwise discrepancy and CAPA systems
• Manage and oversee GMP self inspection program for IMP manufacturing and testing areas including:
• Maintain plan and schedule for self inspection audits
• Coordinate self inspection audits with other subject matter experts.
• Issue audit reports and track corrective actions from audits.
• Communicate to PTDQ-U leadership regarding compliance status
• Provide Quality oversight to GMP IMP Contract Laboratories/Organizations.
• Maintain list of approved contract testing laboratories and corresponding Quality Agreements
• Provide support for establishing new Quality Agreements, revising or renewing existing Quality Agreements, and periodic review of Quality Agreements
• Participate in lab audits as needed
• Serve as the QA representative on cross-functional and multi-site teams.
• Facilitate continuous improvement and the sharing of best practices at the various IMP global sites
• Provide guidance to internal and external customers on best practices for various Quality Systems.
• Mentor and supervise (as required) other Quality System staff members on Change Control, Discrepancy, CAPA, Self-Inspection, and Quality Agreements and or related processes and projects.

The primary mission of the Genentech Research & Early Development (gRED) organization is to discover and rigorously assess promising molecule candidates for viable therapeutic benefits. Within the Early Development segment, the Clinical Operations department is responsible for “first in human” Clinical Trials to assess the benefit and risks of a given therapeutic treatment and is embarking on a 3-year technology program to advance their organizational processes and capabilities.

As the gRED IT Tech Lead, your primary responsibilities are to provide modern technical solutions for the complex business needs in Clinical Operations, to contribute and coordinate IT project work and to support the operational technology landscape within the IT organization. You are a great team player, and self-driven individual who works well with other IT professionals towards the common vision of delivering information systems to enable the company to continue providing novel therapeutics for our patients.

Responsibilities:

• To design, develop, test and implement solutions based on customer requirements with an innovative approach.
• Able to work with customers to gather project requirements and can translate them into a functional solution.
• Provides architectural and engineering input in technical aspects of business planning such as program, project or roadmap planning. Collaborate with Global Architects as required.
• Provides deep technical expertise over a broad set of current technologies and mentoring of other team members in these areas. 
• Within project teams, collects and defines requirements, designs, develops, tests and documents final solutions according to Genentech's project management methodology
• Works with validation teams to ensure GxP validated solutions comply with FDA regulations throughout the solution lifecycle.
• In an operational setting, manages the deployment of software enhancements, troubleshoots production systems, contributes to root cause analyses and adheres to customer SLAs all while providing excellent customer service
• Works with a variety of in-house developed, commercial off-the-shelf (COTS) and SaaS software, across the globe, that provide organizational capabilities to manage Clinical Trials
• Experienced with web programming languages such as HTML, CSS, XML, PHP, Python, Perl and Java on Linux and Windows varieties.
• Experience with Business Intelligence and data warehousing solutions including Oracle databases, Informatica ETL, Business Objects and  Roambi mobile reports.
• Experience with Enterprise solutions including Google Apps, Livelink, Sharepoint, Jive SBS and iOS mobile applications.
• Collaborates with internal and external business partners and can lead contractors and vendors in design, development and testing activities.

The Finance Manager will be part of a team that provides financial planning systems and reporting development, enhancement and maintenance expertise for Roche Canada finance groups and Genentech Commercial finance groups.  The position is located in the United States Eastern time zone and will report to the Finance Manager of Commercial Financial Planning Systems who is based in South San Francisco, CA.  The Finance Manager will be expected to travel to Toronto, Ontario and South San Francisco occasionally – six to eight times per year

The working environment is fast-paced with an ever-changing set of priorities.  The role will interact extensively with the following finance organizations:

The Position:

The Senior Manager of Employee Giving & Volunteerism

The Senior Manager for Corporate and Employee Giving will create an integrated strategy for sponsorships and service and establish an overall volunteerism approach that better engages our approximately 12,000 employees and meets emerging business needs.  The Senior Manager will interact closely with senior leaders from across Genentech to support the company as a great place to work.

RESPONSIBILITIES:

Apply deep subject matter expertise to establish customized service & volunteerism practices that address business challenges including recruitment, retention and skills development as well as enhancing corporate reputation and general employee engagement.

Drive a cross-functional effort to identify strengths, assess gaps and offer solutions that are unique to Genentech. Ensure understanding of operational issues; actively identify strategic opportunities; recommend decision frameworks and present to senior management.

Drive Genentech’s adoption of best practice and cutting edge approaches (eg Pro Bono & skills based volunteerism);

Create and lead plan for successful implementation and socialization across all key stakeholders. Define and measure progress; develop appropriate first-of-a-kind metrics for success.

Manage support staff for volunteerism & employee giving, including outside vendors and internal contractor staff. Provide support for GNE’s employee-volunteer site-based philanthropic giving teams in Oceanside, etc.

Partner with the Principle Manager for Corporate Citizenship in strategic decision-making to support the design and potential launch of a Signature Philanthropic Giving program for Genentech.

Continue to evolve strategy and objectives to ensure ongoing value to the business

CORA 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. CORA Program Directors chair moderate to higher complexity Promotional Review Committees (PRCs), for different products and product development phases, as business needs dictate. CORA Program Directors are responsible for leading and managing the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion for Roche pharmaceutical products and devices. Associate Program Directors are expected to perform their responsibilities with increased independence. 

Intact & Cross-Functional Teams:

• Participates in site, regional and/or global CORA departmental meetings 
• Leads assigned PRCs
• As appropriate, participates as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products. Represents CORA and supports effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution

Commercial Regulatory Affairs:

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for Roche therapeutic areas and products. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics 
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices 
• Maintains current awareness of evolving health authority interpretations; including advisory letters, enforcement letters and policy issues.  Communicates significant changes or other relevant matters to internal partners and stakeholders 
• Facilitates the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from health authorities and Roche policies 
• Manages the development of relevant correspondence with health authorities and interpretation of health authority comments, as well as serving as the primary Roche liaison with relevant personnel in marketing, advertising and communication offices within health authorities 
• Chairs PRC meetings and effectively collaborates with cross-functional internal groups and external advertising agencies 
• Participates in commercial meetings to provide a regulatory perspective on marketing strategies, implementation and promotion objectives 
• Develops and implements effective strategies for health authority marketing, advertising and communications submissions 

Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness. Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer. Performs media/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).

Responsible for assisting the shift supervisor by ensuring production goals are met throughout the day and distributing work assignments to technicians.

Job Responsibilities:
Lead TechnicianLead, coordinate and assign daily operations that include work tasks, breaks, and lunches. Provide coaching and training on technical aspects of the job, best practices and compliance to SOPs.

Assist Supervisor with meeting production quality standards by verifying the environment is in compliance with safe standards and SOPs are followed. Assist supervisor with approvals, communications, and improvements. Identify areas for operational improvement. Provide data to supervisors summarizing schedule status. Resolve employee conflict independently and with supervisor.

Job Matrix
Through knowledge of biopharm technology, processes and the underlying scientific concepts.
Must demonstrate a comprehensive understanding of both general and specific aspects of multiple manufacturing departments.
Troubleshoots, investigates, and escalates complex problems, works with others to implement solutions.

Technician: Operate systems that clean and sterilize tanks and filtration systems.
Prepare solutions for the production process.
Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
Trouble shoot equipment and process problems.
Comply with safety requirements, cGMP, SOP and manufacturing documentation.
Use of automation to perform production operations.
Provide support to Manufacturing to meet production demands.
Operate automated systems for equipment operation.
Assemble and prepare equipment for production.
Exhibit detail oriented documentation skills
Communicate effectively and ability to work in a team environment.
Exhibit professional interpersonal skills.
Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.

We are seeking an outstanding individual for theposition of a Research Associate / Senior Research Associate within theBiochemical and Cellular Pharmacology department. The successful candidate willbe responsible for supporting research projects in the disease therapeuticareas of immunology and/or immunotherapy as part of the biologics drugdiscovery program at our South San Francisco campus. The individual will be expectedto work independently in developing and performing immunochemical, biochemical,and cell-based assays to support candidate selection, potency, efficacy, andpharmacokinetic studies as well as immunogenicity evaluation andpharmacodynamic biomarker measurements. In addition, the individual will incorporateautomation into his/her daily work and apply novel technologies in assaydevelopment.