The QC Pharmaceutical Specialist will be a member of the Method Transfer, External QC, and Method Monitoring group, which is part of ROCHE/GENENTECH’s Global Method Management and Technology (Global MMTech), the department responsible for the life cycle management of all commercial methods and control systems and innovation within Commercial Biologics Quality.
Method Transfer, External QC, and Method Monitoring is responsible for all aspects of assay transfer, QC support of CMOs and partners, and method monitoring activities across ROCHE/GENENTECH’s entire commercial network, including CMOs and partners. The successful candidate will provide QC oversight of Contract Manufacturing Organizations (CMOs) who manufacture and test commercial ROCHE products.

Job Responsibilities:
The successful candidate will be responsible for managing all QC aspects at our CMOs on a global basis as the single point of contact representing ROCHE/GENENTECH. The scope of this role includes all US based CMOs that manufacture and test Commercial Small Molecule Pharmaceutical Products. Responsibilities include, but are not limited to, the following key aspects: Qualify CMO for QC testing and data review; ensure appropriate adherence to cGMP requirements at CMO; work with appropriate subject matter experts to provide support to CMO in QC related investigations and analytical method issues; participate in laboratory audits and inspections; participate on Quality Review Boards as needed; manage change control for all CMO analytical methods and laboratory impacting activities; review and approve documents; manage critical reagents/reference standard supplies for CMOs; support preparation of Annual Product Quality Reports.

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Sr. Planning Manager, Access Solutions  Responsibility & Accounting Quality and Compliance 

The candidate will need to live within the South San Francisco, California area. Relocation assistance will not be provided.

The Quality and Compliance Manager has an advanced knowledge base regarding Healthcare Compliance and Privacy, or Operational Quality. This position is responsible for leading and maintaining all aspects of quality and general compliance within the Access Solutions Organization, keeping abreast of all healthcare and compliance ethics, operational quality measures and the management of external business partners. Additional key responsibilities of this role are: compliance risk management, cross-functional and multilevel partnership, represents the Assess Solutions Organization on compliance related matters.

• Extensive knowledge of organizational leadership and quality models, theories, tools methodologies and processes.
• Deploy change agent strategies in support of organization-wide continuous improvement efforts. Develop teams and participate on them in various roles
• Develop and maintain organizational focus on the importance of quality and performance excellence. Create quality policies and procedures in support of the strategic plan, and integrate those policies and processes into the tactics developed to support the strategic plan.
• Demonstrate management abilities in human resources, financial, risk, and knowledge management applications. Use effective communication methods in various situations to support continuous improvement efforts. Select and use appropriate tools and methodologies to plan, implement, and evaluate projects. Develop, deploy, and evaluate quality plans that can be used throughout the organization. Evaluate and recommend appropriate quality models or systems to implement in various situations.
• Integrate quality and compliance risk/context and business knowledge to address complex problems; provide communications to business partners.  Keep current in the area of healthcare compliance and ethics. 
• Manage, identify and address quality and compliance issues.
• Provide verbal and written communication to internal and external partners regarding clear and concise quality and compliance guidance and context.
• Deliver well organized presentations to leadership the leadership/ senior leadership teams
• Manage outside consultants, vendors, etc., effectively for specific projects with moderate corporate impact within assigned budget guidelines
• Develop resolutions to complex compliance problems, impacted goals, and objectives of business partner groups.
• Act as the subject matter expert for quality/compliance issues/questions.  Represent Access on project teams, multi-disciplinary groups and peers for projects or contracts.
• Interact with business partners on quality and compliance matters of medium to high risks.
• Represent the company as a primary compliance contact on concerns related to Access Solutions.

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Reporting to the Senior Director of North America Pharma Compensation, the Manager of Executive Compensation is responsible for providing compensation services and support for all executive level employees across North America Pharma.  This position will provide expertise, as well as project leadership on all aspects of compensation for executives including but not limited to management of base salaries, short and long-term incentive plan analysis, retention plans, position evaluations, market data and internal equity analyses. This individual will also serve as a senior internal consultant and key thought leader responsible for providing consultation on various executive compensation matters to senior executives and human resources.

Primary Responsibilities:

• Provide expertise in all areas of compensation for executives, including base salary, short and long term incentive programs, job evaluations, market data and trends.
• Oversee the annual salary increase, bonus, and long-term incentive award process for executive level employees.
• Partners with Business Unit Principal Compensation Managers to:
• Develop competitive offers for external executive level hires.
• Develop promotional and off-cycle increases for executives.
• Manage the job evaluation process of new and revised executive level positions.
• 
  
• Prepares all analyses, presentations, speaker notes and materials for management presentations to senior leadership.
• Provide consultation on executive compensation matters to senior leaders and Human Resources.
• Conduct yearly review, analysis and updating of benchmarks and survey results.
• Participates in executive compensation and HR metric surveys for trend and program design information.
• Reporting on current events and regulation updates related to executive compensation as well as maintaining comparator company information.
• Performs other job-related duties as assigned.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.   

Knowledge, Skill, and Abilities:

• Excellent written and oral communication, presentation and interpersonal skills are required to communicate effectively and professionally across various levels of the organization and with key external customers and vendors.
• Proficiency in partnering with business and HR leaders to drive company strategies.
• Ability to establish credibility with numerous constituents and be seen as a thought leader.
• Strong research, analytical, business process analysis and problem solving skills with an internal customer focus.
• The ability and skill to manage multiple projects, maintain momentum and meet deadlines on time and within budget.
• Strong networking capabilities and skills at working moderately complex issues.
• The ability to overcome obstacles and adapt approach to achieve outstanding results.
• Strategic and hands-on approach to compensation including the ability to creatively conceive of concepts and then personally run models to determine feasibility.

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This position may be filled at a Product Manager or Sr. Product Manager 

Senior Product Managers in Managed Care Marketing develop, implement and manage the managed care marketing strategy, plan and tactics for the assigned managed care segments in the U.S. and related territories. 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 in the assigned managed care segments and may also have matrix responsibilities to represent Managed Care Marketing for one or more products or franchises, as assigned.
 

• Plays a key role in development and delivery of the Genentech & Product Value Proposition
• 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 for assigned segments
• 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
• Responsible for expertly creating and managing 3-year and 1-year managed care marketing strategies, plans, and tactics for assigned managed care segments
• 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
• Collects customer insights through advisory boards, strategic councils and focus groups, develops key portfolio resources for MCCO (Managed Care & Customer Operations) field such as disease state/product marketing materials, B2B strategic talking points, eMarketing planning and execution, and training the MCCO field in all such tools
• 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

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Senior Finance Manager - Commercial Finance

The Senior Finance Manager is responsible for providing financial management and value-based business decision support to the Nutropin and Pulmozyme Franchises within the Genentech Commercial organization. This position reports to the Director, IMPACT Decision Support within Commercial Finance, and could be a Finance Manager depending on the candidate’s background and experience.

 

RESPONSIBILITIES

• Act as a business partner who adds value by understanding the needs of the business and proactively identifying opportunities that drive financial results
• Act as an internal consultant by providing financial consultation and guidance to business partners as needed; support business in understanding state of finances and tactical/corrective actions required to achieve objectives
• Partner with brand teams on business development opportunities to provide financial/value perspective.  Build Xcel-based financial models to influence and drive negotiations and deal participation
• Conduct forecasting and analysis of marketing and sales expenses in support of business planning deliverables (10-year Business Plan, 3-year Brand Plan, 1-year Tactical Plan/Budget, quarterly corporate forecast submissions)
• Conduct month-end close for brands – review posting of appropriate journal entries by Finance Analysts and provide explanations on variance/performance drivers to Nutropin and Pulmozyme Brand Teams
• Monitor compliance with financial policies and recommend/take actions as needed
• Prepare and present financial reports requiring translation of complex quantitative data to multiple levels of business partners
• Conduct financial data mining and value-based business analysis to provide insights and guidance in support of business decisions and objectives
• Build and maintain effective partnerships with Product Managers, Marketing Directors, Franchise VPs as appropriate, and others within Commercial Finance
• Support strategic projects for IMPACT and Commercial Finance as needed to inform business decisions
• Mentor and develop Financial Analysts (indirect report)
• Participate in process improvement initiatives within Commercial Finance

COMPETENCIES

• Demonstrates theoretical/financial and cross-functional understanding in financial problem solving; works effectively on issues where analysis of situations or data requires in-depth evaluations of variable factors with intra-Commercial impact; demonstrates judgment in selecting methods and techniques to solve routine financial and tactical problems of moderate scope and complexity; contributes sound ideas in developing recommendations for more complex problems; anticipates problems and offers solutions
• Solid experience and facility with distilling business development and M&A situations into key drivers that can be modeled in Xcel
• Interacts and collaborates effectively within workgroup and area of expertise; participates effectively on cross-functional teams; offers views and actively solicits ideas from others in seeking sound business solutions; encourages others in fostering effective teamwork; demonstrates very strong customer service orientation
• Gets point across clearly, with straightforward language, both verbally and in writing; considers the needs and interests of others and incorporates information relevant to them in communications; readily grasps the main points in communications from others
• Plans, prioritizes and reports status on tasks; operates independently with limited supervision, holding self accountable to fulfill assigned tasks and achieve results within timelines; establishes own work priorities and timelines within scope of authority; responds to requests with appropriate urgency and an organized approach; may provide guidance and coordinate work activities of others
• Monitors process effectiveness and efficiency against goals and objectives, taking corrective action as necessary; identifies, implements, and supports complex process improvements
• Understands strategic priorities developed by upper management; recognizes relationship between workplace results and what caused them; able to shift between tactical and strategic perspectives based on audience and project needs

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Job Duties/Responsibilities

• Leads the development, planning, directing and tracking of the validation of GxP computer systems operated by North American ERP team (i.e. SAP ERP, BW, APO, XI, Solution Manager, GRC, Portal and Business Objects).
• Responsible for the quality systems and processes that ensure computer systems are operated and maintained a validated state. This includes all modifications and / or changes to systems or processes, change control, periodic revalidation activities and ensures a continual state of inspection readiness with regard to cGxP’s.
• Leads the Information Technology and Quality team members to develop and implement validation strategies in accordance with company policies, directives and government regulations.
• Develops and writes validation project plans, master validation protocols, acceptance criteria traceability matrices and summary reports by providing instructions and scientific rationale for the performance of validation studies.
• Leads fellow technical and analysis team members in ensuring quality systems and processed are in compliance with corporate quality directives, policies, standards and procedures.
• Responsible for the maintenance of departmental quality systems and procedures to assure compliance with new and revised corporate standards and policies.
• Coordinates the testing efforts of the IT and business teams with regards to requirements, resource planning, test coverage, test strategies for the orth American SAP systems.
• Coordinates and interacts with all affected personnel in the execution of test scripts and validation protocols and gathering of test data. Ensure all protocol executions are documented and recorded in accordance with company quality policies, quality standards and SOPs.
• Reviews and approves validation data to assure protocol acceptance criteria is achieved and all deviations are completed and recorded according to procedures.
• Ensure all final reports are completed according to procedure.
• Coordinate and manage the application release cycle processes.
• Manage the life cycle documentation.
• Recommends methods for process improvement, detailing process strengths and weakness of existing and proposed procedures and controls
• Participate in internal and external vendor audits and regulatory audit teams.
• Define and maintain GxP training program to support compliance requirements for IT staff.

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This position involves global medicine development activities of a novel biologic agent targeting indications in the field of respiratory diseases.

This job creates a unique opportunity to join a global team that is currently defining its structure and both short-term and the long-term deliverables, and to grow with the team and the franchise.

 As the Medical Director you will be responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within one or more programs. You will also participate in developing the long-range strategic plans for the molecule or molecules within the area of inflammatory diseases.

Key Accountabilities will be:

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

Participation in on-going medicine development activities including:

• Preparation of regulatory documents and interaction with global regulatory authorities
• Monitoring and reviewing incoming data
• Analysis, presentation and interpenetration of on-going studies and published data
• Interactions with health authorities and expert bodies
• Close collaboration with drug safety, regulatory affairs, medical affairs and clinical trial operations
• Participation in the preparation of abstracts, posters and presentations for scientific meetings and congresses
• Developing and writing clinical plans and protocols ensuring that they are scientifically sound

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

• Solid experience in medical research including writing clinical study reports and interpreting clinical data
• Good communication and collaborative skills with experience at working with cross functional and external groups, including researchers, clinicians and other stakeholders.
• Proven track record of delivery of experimental or novel studies
• Confidence at presenting at internal and external strategy meetings

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GCP experience required for consideration

 

Position Purpose

The Inspection Specialist supports the Roche/Genentech Pharma and gRED/pRED organizations by coordinating, managing, and preparing for Good Clinical Practice (GCP), Pharmacovigilance (PV), and Investigator Site inspections conducted by global health authorities.

Major Responsibilities and Accountabilities

• Coordinates scheduling and logistics for inspection related activities.
• Collaborates with other Pharma / gRED / pRED functional areas for activities related to inspection preparation.  Activities include, but are not limited to, preparation of relevant materials and conducting inspection related training.
• Participates in pre-inspection visits of investigator sites ( approximately 20% travel).
• Participates in health authority inspections and helps ensure that roles and responsibilities have been defined and assigned for each inspection.  Assumes a role as required by the scope and nature of the inspection.
• Provides guidance to inspected parties regarding the completion of inspection corrective and preventative action plans (CAPAs).
• Assists in the preparation, conduct and management of mock inspections conducted of Roche/Genentech functional areas.
• Assists in developing and maintaining policies, standard operating procedures (SOPs), and guidelines for preparation and conduct of inspections within Roche/Genentech Pharma.
• Assists in preparing periodic summary reports and trend reports related to Roche/Genentech inspections.
• Develops and maintains expertise in international GCP regulatory requirements, international PV regulatory requirements, and policies, SOPs and project-specific procedures within Pharma applicable to the clinical trial methodology and Pharmacovigilance processes.
• Monitors trends in health authority inspection activities to proactively identify potential areas of risk for Roche/Genentech.
• Responsible for the coordination of Inspection Readiness (IR) modules and if required provides a country-specific / function-specific summary report.
• Provides support to the IR Program Manager.
• Provides support to and communicates with Inspection Readiness Key Contact (IRKC) personnel globally.
• Assists in identifying needs for updates to training materials, IR modules and all documents required for the IR program.

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The senior DBA manager leads and manages a staff of Database Administrator (DBA) professionals for Genentech database environment that includes Oracle and SQL Server. The individual will work with other global IT team leaders to translate the organization's IT strategy into specific database roadmaps and deliverables, measures the effectiveness of the delivery model, and track progress against plan and operational Service Level Agreements (SLA). The individual will provide management and implementation of strategic initiatives for the enterprise databases services in the charge toward efficiency and optimization. In addition, the individual is responsible for developing processes and procedures for overall IT Operations, upgrading and maintaining IT processes,production controls, capacity planning, and system backups and recovery. 

Key Strategic Objectives

* Lead the organization through organizational change, technology transformation, and sustained growth while exhibiting excellent judgment on how to prioritize between operational excellence and financial prudence

* Drive successful creation of a strong team dynamic in a collaborated and risk-taking

culture. Translate the organization's strategy into tactical execution plans replete with key performance measures and monitor the results on regular basis

* Improve Genentech's return on invested capital by having a systematic capacity planning process to maximize the utilization of assets and increase the velocity of infrastructure investment in virtualization and cloud computing.

* Build and develop future leaders of the organizations while advancing Genentech's image as one of the best places to work in America.

Responsibilities:

• The right candidate for this position is well organized, and an exceptional communicator with his/her team, peers, executive management, and the company. 
• This person must be able to lead and manage change. The individual will live by metrics, staying ahead of the tactical while also deeply understanding the needs of various business teams to appropriately plan for growth and change.
• Demonstrated ability to lead and energize multidisciplinary teams with gifted communication and interpersonal skills. 
• Demonstrated analytical, problem-solving and conceptual skills. 
• Ability to analyze project needs and determine resources needed to meet objectives. 
• Demonstrated negotiation skills with vendors or management and ability to influence management regarding matters of significance to the organization. 
• The successful candidate must be able to establish credibility very quickly in organization with shifting priorities. 
• The individual must be a strong leader who can prioritize well, communicate clearly and compellingly and who understands how to drive a high level of focus and excellence with a strong, talented, opinionated team.
• The individual will have a technical aptitude particularly in the database domain and be credible as leader in a technical organization. 
• The individual will be able to articulate with full clarity the aspiration of his teams, and achieve results through influence and leadership rather than direct authority...

Genentech is seeking an AssociateMedical Director/ Medical Director to join the Ophthalmology Medical Affairs organization. The candidate will support medical affairs activities for high visibility ophthalmology programs which are currently in Phase III of development for several indications. Responsibilities will include providing medical expertise on cross-functional teams and provide clinical support for the commercial organization, participating in life cycle management activities through Life Cycle Team, building scientific relationships with internal and external experts, and working closely with the Medical Science Liaison team. This individual will also have a strategic role in expanding late-stage clinical development opportunities, which may include the strategy development and implementation of clinical trials. This role will be pivotal for planning and participating in launch readiness and launch-related activities, and evaluating new pipeline opportunities with the business development group....

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.

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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.

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• 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.

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