Purpose: 

The Safety Science Leader (SSL) is accountable for all aspects of safety related to a product in the Life Cycle Team (LCT) stage including single case assessment, aggregate reporting, signal detection, risk management throughout the life cycle. The Safety Science Leader leads product specific safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate. Accountability is partially exerted by the bringing of safety topics to the Development Subteam (DST) and, when appropriate, the Life Cycle Team (LCT) to ensure that adequate safety measures are implemented, based on data, and that CIOMS 6 guidelines are followed. 

Primary Responsibilities and Accountabilities:

• Contributes to scientific publications (abstracts, posters, papers) for scientific meetings/journals and approves submissions from a safety perspective. 
• Reviews all communications to the public from a safety point of view. 
• Keeps the EU QPPV fully informed of any changes to the benefit-risk relationship and, where appropriate, performs tasks as delegated by the EU QPPV. 
• With the CSL and the DST, plans and performs, on an ongoing basis, an evaluation of the safety data to detect safety signals. On an ongoing basis with the team, evaluates the Benefit/risk relationship of the program and determines how to manage patients within and across trials.
• Is accountable for safety components of all NDA documents. 
• Is responsible for the writing and maintenance of RMP/REMS NDA documents. 
• Represents Roche in interactions with Health Authorities and Independent Data Safety Monitoring Boards (ie Pre-BLA/NDA meetings, advisory committees) for safety related topics.  
• Contributes to and where specifically delegated may be responsible for the proper execution of the post-approval RMP/REMS 
• Ensures that all safety processes are properly supported and compliance is documented for all studies conducted by PD or PB or affiliates. 

People Leadership: 

• Provides provide leadership and line management to the Safety Sciences department across multiple locations, aligning with other parts of the organization, where necessary. 
• Ensures that the performance of direct reports is proactively managed and that they are coached, trained and developed to maximize their contributions.  
• Allocates resources and is accountable for the assignment of his/her collaborators / reports according to their individual capabilities and in line with projects priorities.
• Ensures that staff communication and employee relations are managed proactively to maximize the well being of employees. 
• Actively installs the Roche values in the Safety Team and their activities.

Note: Position can be filled as a QC Pharmaceutical Specialist II (E4) or Sr. QC Pharmaceutical Specialist (E5) based on education and experience.

QC Pharmaceutical Specialist II Role
The QC Pharmaceutical Specialist is a member of the senior technical staff of the QC Microbiology/Environmental/Molecular team specializing in microbiological challenge studies (i.e. disinfectant efficacy testing, antimicrobial effectiveness), sterility testing method and isolator validation, as well as deviation assessment/management.

Main Purpose of the Position:   
• Develop solutions to complex Quality Control testing activities and issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards. 
• Perform tasks and work to achieve company goals and organizational objectives.

Job Duties/Responsibilities:
• Follow company policies and procedures.
• Set personal performance goals and provide input to departmental objectives.
• Establish work priorities to meet targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned department resources.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• 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 and author department policies and procedures.
• 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.
• Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
• Meets scheduled performance of 95% on time.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Provide technical expertise in the development of test method validation protocols and supporting procedures.
• Ensure validated methods and supporting procedures adhere to approved regulatory specifications.
• Prepare validation summary reports for test method validation activities.
• Provide input into regulatory filings.
• Perform Quality Control testing for product release and stability samples.
• Support quality investigations for testing and test method discrepancies.
• Perform equipment validation for laboratory instruments used in cGMP testing activities.
• Provide input into the generation of stability study protocols.
• Collaborate with departments to ensure product release and stability testing requirements are completed.
• Communicate testing or scheduling issues that may impact the timely release of final product to Quality Control Management.
• Compile trending reports for method validation and testing activities.
• Develop and deliver training materials for new and revised test methods and laboratory procedures.

The Discovery Oncology department is seeking an exceptional and highly motivated scientist to join a team focused on the discovery and validation of novel oncology drug targets and the discovery of biomarkers predictive of the clinical efficacy of novel cancer therapeutics. Current efforts of this team are largely directed to developing a mechanistic understanding of tumor cell sensitivity and resistance to molecularly-targeted anti-cancer agents. Aspects of cancer cell biology of particular interest include epigenetic regulation and intra-tumor heterogeneity.

MSDs are generally expected to perform their responsibilities with limited guidance from Medical Directors and/or other relevant internal partners and stakeholders:

·         Implement the medical affairs plan for the assigned drug(s) /indication(s), working with Medical Directors, mainly on PhIV clinical programs and their publication plans

·         Collaborates with Commercial and provides scientific input for the development and review promotional materials, documents and presentations developed for the assigned drugs and/or indications (signing off of any promotional material remains the responsibility of the Medical Director of the assigned drugs and/or indications)

·         Support his/her manager, as and when requested, in developing relevant parts of the medical affairs tactical plans, and/or completing other special projects such as preparation and review of training materials for field forces

·         Demonstrate ever-increasing competence in implementations of all aspects of medical plans

·         Competently and collaboratively interact with a host of internal and external partners and stakeholders

·         Consistently complete all assigned responsibilities on-time and on-target.

·         Develop and cultivate important relationships with internal and external partners and stakeholders. Includes investigators, thought leaders and KOLs (key opinion leaders)

·         Stay informed and abreast of the external landscape as it relates to assigned drugs and/or indications and the associated therapeutic area(s)

JOB DESCRIPTION - PRIMARY DUTIES AND RESPONSIBILITIES:

1. Clinical Trials & Programs 

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 GNE Medical Affairs, 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

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• Acts as a subject matter expert and specialist point-of-contact for internal staff and management and external vendors involved in the distribution and/or administration of Genentech promotional goods:

• Receives and reviews all incoming requests/inquiries
• Reviews incoming promotional goods requests or other inquires in accordance with governing rules, regulations or other policies and procedures to ensure consistent and full compliance
• Provides timely responses and other information to internal and external customers, partners and other stakeholders
• Enters all requests and other information into appropriate departmental or other systems or databases
• Responsible to ensure that departmental systems and/or databases contain current and fully accurate information
• Performs routine and ad hoc analyses and reporting

• In partnership with Vendor Manger, visits promotional goods vendors and
• performs compliance and other operational audits
• Performs routine and ad hoc audits on promotional goods distribution managed by Genentech field staff and management
• Produces audit reports. Reviews with manager and others. Distributes to various parties.  Identifies and communicates potential or existing issues and recommends steps and activities to mitigate risks of non-compliance or other potential concerns
• As and when appropriate, participates in various meetings or conference calls to determine promotional goods needs, requirements, and/or communicate new or updated regulations, policies, procedures or other changes
• Supports manager and other team members, as and when/how needed, to cover for any staff shortages within the department
• Works with manager and other team members to continuously review department processes, procedures, tools and other resources to ensure best practices, optimal efficiencies and effectiveness
• Supports his/her manager and other team members in ongoing training, mentoring and coaching of less experienced analysts
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

Location: San Francisco

Research, Facilities, and Procurement Services

Primary Purpose of Job (Job Summary)

The Category/Souring Manager, Facilities Procurement is to provide strategic leadership to the Facilities Procurement organization in support of Global Categories related to Facility Operations and Services.  This position is responsible for: establishing full strategic planning (Regionally and interfacing Globally) on behalf of the Facilities Procurement function in alignment with the Pharma Business and Corporate goals and objectives; identifying and introducing best practices in the Facility Procurement processes; acting as a change agent who supports and influences the business in an effort to create value and efficiencies across the Global and NA Regional networks; focusing on return on investment benefits, Category Lifecycle Management and Total Cost of Ownership; evaluating savings opportunities in partnership with key business partners and stakeholders and maximizing the value of third-party services across a portfolio of sub-categories.  The Global/Regional Category Manager will lead cross functional teams through strategic category sourcing to deliver breakthrough business benefits.

Functional Roles & Responsibilities

The Global/Regional Category Manager, Facilities Procurement will have a Category Strategic and Supplier Management focus of assigned Global/Regional Categories related to Facility Operations and Services.  This position leverages category management expertise to manage the purchases of goods and services, with the aim of achieving optimal total cost of ownership.  This position provides end-to-end strategic solutions, from idea generation through to presentation to senior business management and initiative execution and will fully utilize the eSourcing tools including eAuctions when appropriate to drive the costs down and out across the assigned categories.

Responsibilities:

* Develop strong working relationships with internal teams, key business partners and leaders throughout the Global and Regional organizations/networks.  

* Partner with global colleagues to develop and implement the global category management roadmap.

* Build and maintain excellent relationships with key affiliates, Roche group companies, and global functions so that Roche collectively benefits (e.g. global savings, service delivery, vendor selection, etc.).

* Partnering with stakeholders and business partners to identify and support sourcing projects that reduce risk, timeline, stakeholder pain-points or cost and add value without sacrificing quality or effectiveness.

* Lead and/or partner with various multifunctional teams on strategic initiatives which also include accountability for implementation planning and tracking of expected outcomes.

* Aligning the priorities, activities, and progress of goals across the Facilities organization, so that high value and quality customer service is delivered.

* Provide Strategic Category and Supplier Management:

o Develop an advanced understanding of category subject matters to include Analyzing Category and Supplier Spend history, trends and forecasts

o Establish and manage robust Supplier Relationship Management programs for Strategic/Key suppliers

o Lead Category activities and Sourcing Managers in the development and execution of the spend category sourcing strategies for key initiatives.

o Develop detailed supplier knowledge, market data, including financial performance (P&L, balance sheet, debt structures, trends, history, executives, ownership, parent companies, size, concentration of sales to GNE, diversity of sales volume)

o Analyze past and future demand volumes, inventory trends and current inventory levels

o Document supply-chain for key goods and services

o Identify opportunities that focus on cost reductions, efficiencies/quality improvements, risk mitigation, industry and supply trends and shifts in technology

o Lead sourcing projects including sourcing strategy development, market analysis, and supplier negotiations, and supplier relationship management

o Monitor Strategic/key Suppliers (earnings, SEC filings, RSS feeds, Alerts) to provide internal notifications to key stakeholders that includes developing risk mitigation scenarios

o Ensure Diversity Suppliers are included in sourcing events

o Know, understand and stay abreast of industry trends, benchmarks, best practices, etc.  Develop and implement a strategy to gain competitive advantage.

* Facilitate senior level review and concurrence on sourcing strategies, including sponsorship and resource allocations.

* Demonstrate advanced industry knowledge and facilitation skills so that this role leads the negotiations of contractual requirements that includes managing complex RFP/RFIs, making sele...

Position description and responsibilities:

A position is available in the Protein Analytical Chemistry department for a Scientist with appropriate analytical skills and biopharmaceutical industry experience. The candidate must have strong understanding and hands-on experience in analytical characterization of recombinant therapeutic proteins, development of quality control methods, and application of emerging analytical technologies. The candidate should have experience in or be highly familiar with the development of analytical methods covering a wide array of techniques such as HPLC, CE and mass spectrometry. The Scientist will design and execute analytical characterization studies to identify critical quality attributes for each product. A strong understanding and knowledge in analytical control strategy development and cGMP is highly desirable.

The Protein Analytical Chemistry department is part of Genentech's Pharma Technical Development Biologics organization and is responsible for method development and detailed structural characterization of recombinant proteins to support the clinical and commercial biotechnology product portfolio.

The PD Clinical Operations / Biometrics / Clinical Science Informatics team (part of FPPO) is looking for a senior Business System Analyst (BSA), with in depth Business analysis experience in the Pharma/Biotech industry and the ability to strategize, recommend and implement solutions with an end-to-end process filter that will meet the short and long term needs of Clinical Operations.

The senior BSA is responsible for exploring, scoping, planning and supporting the successful implementation of solutions by providing business analysis, best practice research, detailed requirements definition and user acceptance facilitation.

We are looking for an individual with strong customer focus, experience in working in global, multi-cultural environments, with a structured working approach and excellent analytical and communication skills. 

FURTHER RESPONSIBILITIES / DUTIES ARE:

• Participate and conduct strategic / exploratory workshops to identify / plan / execute innovation experiments and to contribute to robust roadmaps supporting the business strategy. Example: resource may participate to the Trial2Patients initiative 
• Collaborate with business and informatics stakeholders to lead business case development for new initiatives as well as business case tracking for completed initiatives.
• Plan early stage project efforts; specifically, requirements gathering, assessment and scoping, and project initiation and funding.
• Plan and facilitate workshops and end-user working sessions intended to surface requirements and validate designs.
• Take active role in preparing initiatives for portfolio committee and approvals at appropriate project milestones.  
• Collaborate with other BSMs / BSAs across functions and regions to identify and address business problems and opportunities, evaluate alternative informatics technologies and research industry best practices and emerging trends.
• Collaborate with Project Managers, Architects, Engineers, Developers, and Designers on scope, solutions, constraints, and risks
• Analyze document current and future business process models
• Take responsibility in ensuring the solution meets the customer needs. Support operational services teams in ensuring continued business value realization and business adoption.
• Collaborate with BSMs / BSAs within function and across functions to continuously harmonize and further develop skills and working practices specific to the BSM/BSA community within the organization 

Note: Position can be filled as a QC Pharmaceutical Specialist II (E4) or Sr. QC Pharmaceutical Specialist (E5) based on education and experience.

QC Pharmaceutical Specialist II Role
The QC Pharmaceutical Specialist is a member of the senior technical staff of the QC Microbiology/Environmental/Molecular team specializing in environmental/utility monitoring support for biotech drug substance production and aseptic filling.

Main Purpose of the Position:   
• Develop solutions to complex Environmental/Utility monitoring activities and issues.
• Lead Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards. 
• Perform tasks and work to achieve company goals and organizational objectives.

Job Duties/Responsibilities:
• Follow company policies and procedures.
• Set personal performance goals and provide input to departmental objectives.
• Establish work priorities to meet targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned department resources.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• 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) for Environmental/Utility Monitoring 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 and author department policies and procedures.
• 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.
• Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
• Meets scheduled performance of 95% on time.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Provide technical expertise in the development of test method validation protocols and supporting procedures.
• Ensure validated methods and supporting procedures adhere to approved regulatory specifications.
• Prepare validation summary reports for test method validation activities.
• Provide input into regulatory filings.
• Participate in internal and external audits and regulatory inspections.
• Perform Quality Control testing for product release.
• Support quality investigations for testing and method discrepancies.
• Oversee equipment validation for laboratory instruments used in cGMP testing activities.
• Identify, initiate and approve change records to GMP controlled documents and electronic systems as appropriate.
• Collaborate with departments to ensure product release requirements are completed.
• Communicate testing, scheduling, or Environmental/Utility Monitoring issues that may impact the timely release of final product to Quality Control Management.
• Compile trending reports for method validation, testing activities and Environmental/Utility Monitoring.
• Develop and deliver training materials for new and revised test methods and laboratory procedures.

The Advisor PEM advises and supports the Medical Unit Head of Operations. The Advisor PEM has the operational responsibility for the performance of assigned Medical Teams. This is a leadership role with responsibilities for providing input into design, development and execution of post-marketing activities; supporting medical teams in the mitigation of risks and the delivery of successful outcomes.  Advisor PEMs are assigned PEM responsibilities for multiple and/or complex or large-scale multiple molecules/products with potentially multiple indications. Advisor PEMs are also expected to take a leadership role in gMed initiatives, when needed, act as a substitute for his/her manager, assist his/her manager and others with on-boarding, training and coaching new PEMs, and if appropriate, have 1-2 direct reports.

Responsibilities:

The areas of major responsibility include, but are not limited to the following:

• Responsible for the day-to-day operations of the designated Medical teams.

o Works closely with medical directors and other cross-functional partners /teams to support the development of short and long-term medical strategy, plans, tactics, budgets and other resource plans for multiple and/or large-scale or highly complex molecules

o Co-leads and facilitates all medical team planning and decision-making

o Identifying and initiating problem solving strategies when operational issues arise and escalates issues if unresolvable.

o Plays a lead role, working with finance, legal and other partners to evaluate medical plans, develop budgets and determine any legal or other administrative implications or requirements necessary to execute projects.

o Works with team members and other stakeholders to ensure alignment of gMed strategies, plans and objectives with Genentech strategies.

o Co-leads process to develop the medical plan vision, strategy, scope, milestones, risk assessment and management strategies, project investment requirements and success metrics 

o Supports medical directors and/or plays a lead role in development and delivery of critical presentations to communicate, obtain inputs into and approval for medical plan strategies, objectives, tactics and resource requirements 

o Works with cross-functional medical team members and other partners/stakeholders to implement project plans to ensure timely, on-target, and within-budget execution

• Builds and maintains relationships with key internal/external customers, partners and other stakeholders, includes global partners, external strategic partners, etc.

• Works with manager and other team members on key departmental projects, including standardized gMed and/or MU specific Planning & Execution SOPs, other protocols, processes, systems, tools, etc. 

• Oversees all project/program phases to help ensure on-time, on-target and within-budget execution 

• Conducts proactive risk assessment and change control for all assigned projects/programs

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

Sales Compensation Administration - Analyst / Manager

The Sales Comp Administration - Analyst / Manager role is to support the Sales Operations Incentive Compensation team for all business units / sales forces in administering Sales Incentive Compensation Programs which includes ad hoc analysis and reporting. As such the Sales Comp Administration - Analyst / Manager will be responsible for all sales compensation administration aspects including the maintenance of all sales force reference data, variable pay information, and compensation plan information within the compensation systems (TrueComp) and Incentive Compensation platforms. Additionally they will work with the Business Unit Comp Managers to collect plan design information and be responsible for the oversight of development and testing of compensation plans and rules in TrueComp. He/She will support and maintain the monthly sales and goal validation process, which requires critical thinking and problem solving skills. Candidate will also manage department SOPs, prepare department activity timelines, maintain documentation for various purposes such as program policies, eligibility, auditing & OCM purposes. Candidate will also support multiple supplemental incentive programs including the management of processing guidelines to ensure accuracy and consistency including application design & management. He/She will also help manage awards program documentation, criteria, history, inventory, etc. He/She will maintain content on IC Portals and facilitate process/data management with vendors. Candidate must have SQL skills for querying data and a basic understanding of sales compensation philosophy. Candidate will proactively coordinate with internal partners to ensure data accuracy, optimize operational processes and meet aggressive timelines. Provide adhoc support and analysis, including running queries and producing reports (using Access, Brio, Toad or other sql tool). Strong technical, stakeholder manager and communication skills are required.

Key Responsibilities:

- Primarily responsible for the administration and management of all sales incentive compensation administration deliverables including oversight of system configuration for IC plans, reference data (e.g. eligibility), timely and accurate payout processing, supplemental incentive programs, reporting and reference data management for all brands.

- Partner with Sales Operations Managers, Vendors and/or the Information Technology team to define data and reporting needs in support of the IC payout process and supplemental incentive programs.

- Collaborate with various internal and external stakeholders to ensure fairness and consistency in the implementation of and adherence to program policies.

- Communicate with field sales management in support of the sales incentive program payout process and provide supplemental incentive programs summaries.

- Development communication and reporting materials to support IC administration activities and status reports.

• Manage and track the Validation program and assigned validation projects and ensure target
• timelines are met and/or issues are communicated / escalated effectively and consistently.
• Generate, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents.
• Generate, review and approve a variety of Validation protocols (IQs, OQs, IOQs, PQs, SIP, CV) for equipment.
• Manage protocol execution, perform data review and manage deviation resolution.
• Oversight and management of validation contract resources including work prioritization, execution and contractor budget.
• Strong understanding of commercial production environment and requirements.
• Evaluate and audit the current validated status of equipment/systems temperature mapping and cleaning validation program.
• Proven ability to make suggestions for improvements as well as ensure programs are operating in a compliant and validated state.
• Present validation packages as required for audits and/or regulatory inspections.
• Perform role of subject matter expert and assess change control and discrepancy events for to validated systems.
• Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP’s).
• Participate in cross-functional team meetings and where required, lead/facilitate meeting.
• All employees with jobs that require access to the Warehouse must be able to pass the
• Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Ensures there will be integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within their functional area.

This positon may be filled at an Associate Contract Manager or Contract Manager  level.

The Managed Care Contracts Group manages the contracting process from development of an account-centric contract strategy through execution of an agreement. The Associate Contract Manager, Managed Care Contracts develops, drafts, analyzes, negotiates and gains the necessary approvals for the assigned managed care accounts and contracts.

• Works closely with Contract Managers and other internal partners in reviewing customer contract needs, requirements, etc. in alignment with GNE contracting strategies, business objectives, and other contract conditions
• Conducts various analyses and modeling of appropriate contract terms and reviews with key internal partners/stakeholders
• Obtains all appropriate and required internal reviews and approvals for contract terms and provisions
• Develops language and drafts contracts and related documentation
• Responds to various partner/stakeholder questions, inquiries, requests for clarification, etc. regarding contracts and terms/conditions or other items
• Ensures execution of approved and finalized customer contracts; including timely and accurate hand-off to other internal partners/stakeholders
• Monitors existing customer contracts using approved performance methodologies, tools, etc.; includes identifying and recommending opportunities for improvement
• Ensures all contract data and information is appropriately entered into relevant systems/databases
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Business travel, by air or car, may be required for regular internal and external business meetings

The AE&O Senior Project Manager scopes, plans and manages local, regional and global IT projects consisting of one or more delivery streams. He/she works with solution owners and project sponsors within AE&O (Architecture, Engineering & Operations) and SP&A (Shared Platforms & Applications).

As part of a team of project management professionals he/she reports to one of the Team Leads of Project Management within AE&O Project & Portfolio Management and is supported by portfolio analysts of the AE&O PMO and SP&A PMO (if applicable).

The Senior Project Manager is responsible for scoping, planning, managing and controlling global IT projects and reporting in a timely, accurate and transparent manner following standardized methods to allow accurate portfolio management and project execution control within AE&O and SP&A.

The senior project manager works closely with a responsible portfolio analyst from the PMO in AE&O (or SP&A) to ensure timely and accurate project reporting on project scope, schedule, cost and resources, as well as project risks, issues, action items, and dependencies.

In addition the senior project manager needs to collaborate closely with the Finance, Quality & Procurement departments as required. Also the involvement of other Pharma IT areas outside of AE&O and SP&A (as internal project workforce) might be required (e.g. Roche’s Shared Service Center in Warsaw).

Major Responsibilities include:

• Project Scope Management - Formulating and defining scope and objectives of the project in collaboration with the responsible Solution Owner and ensuring communication of project goals, schedule baselines, and business direction to all identified stakeholders
• Project Stakeholder / Communication Management - Identifying all relevant project stakeholders and establishing and implementing an appropriate communication plan to manage their requirements
• Project Delivery Primarily - Delivering the project on time, on approved (baseline) budget, within quality limits, and with the expected benefits, as defined at project entry and project baseline gates and through controlled and documented change management throughout project delivery, as needed
• Project Risk, Assumption, Issue and Dependency (RAID) Management - Actively managing risks, assumptions, issues and dependencies (RAID) by carefully assessing potential impacts in collaboration with the respective project teams and proposing appropriate mitigation actions. Is also responsible for identifying, actively managing and integrating with any dependent projects or activities.
• Project Planning, Tracking, Control & Reporting - Creating baseline project schedules and tracking the completion of project deliverables, tasks, activities and milestones. Providing accurate, timely and fit for purpose project status reports using established norms and reporting tools of the portfolio
• Team Building & Leadership - Organizing and supervising the appropriate involvement of project resources and actively managing and addressing the resolution of conflicts within the project team.
• Compliance – Directly accountable for ensuring compliance with project management, portfolio management and CSV policies, guidelines, process tools and reporting standards of the portfolio. These norms will include all system qualification/validation state documentation, project documentation and resource forecasting/tracking, financial forecasting/tracking and governance procedures of the portfolio for the specific projects assigned

The DMPK group is dedicated to enabling the discovery, developmentand commercialization of safe and effective medicines by elucidating theabsorption, distribution, metabolism, excretion and pharmacokinetic propertiesof small molecule drug candidates. We accomplish this through the applicationof state of the art technologies and sciences of bioanalysis, drug metabolism,drug transport and pharmacokinetics. The DMPK group works in close partnershipwith disciplines such as medicinal chemistry, pharmacology, toxicology,pharmaceutical sciences, clinical pharmacology and regulatory to optimizeleads, select clinical candidates, conduct preclinical development studies,support clinical evaluation and contribute to IND and NDA filings.

We are seeking a candidate to support both in vitro and in silicoADME.  The candidate will work with anestablished team on various in vitro assays and will collaborate with otherscientists in the group to perform hypothesis-driven studies to address ADMEquestions.  On the in silico side, thecandidate will apply ADME models to support projects and maximize the value of existingADME data. They will work at the intersection of modeling ideas, modelgeneration and experimental investigation to support/build SAR and meet projectneed.  A key part of the role will becontinuing education in the department on use of predictive DMPK and championinguse of in silico tools. The candidate will be a highly effective and energizingcollaborator and will work scientists from multiple disciplines including computationaland medicinal chemistry, safety assessment and pharmaceutical sciences.

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