Job Summary:

Perform analytical, biochemical testing and related activities to support QC operations

Description:

Must have flexible schedule, 4x10 day shift schedule. This role will require working major holidays.

Perform analytical, biochemical, and/or biological cell based testing of commercial and clinical in-process, drug substance, drug product and stability samples to meet standard lead times to support Quality Control Bioanalytical  / In-Process operations. 

Technical Duties/Responsibilities:
•Perform testing of routine and non-routine samples (e.g. Spectrophotometry, pH, HPLC) and document according to GMP.
•Review data and assess against established acceptance criteria
•Perform technical review of peer-generated data for basic methods
•Prepare data tables and graphs
•Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.
•Receive and provide training
•Participate in assay transfer and assay validation.
•Perform 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 under supervision.
•Meets scheduled performance of 95% on time.
•Perform other duties as requested by managers to support Quality activities.

Note:
•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.
•Must be able to lift up to 10 lbs
•Repetitive pipeting

• Managing electronic calendar, scheduling & global meeting management including coordination of telepresence, videoconference, teleconference meetings and meeting materials
• Creating, editing presentations, spreadsheets and word documents, proofreading and compilation of special reports.
• Handling correspondence and shared electronic filing system
• Making extensive international travel arrangements.
• Preparing expense reports.
• Initiating and managing purchase orders and contract processes including PO, invoices and payment tracking.
• Arranging various recruiting activities such as on-site interviews.
• Coordinating meeting and conference arrangements, planning off-site, town hall meetings, and organizing catering
• Leading the PTD administrative team meetings to ensure alignment, awareness of new business processes, and create a sense of community. 
• Delegating various departmental administrative responsibilities and supporting the growth and development of the PTD administrative team.

Product Manager or Sr. Product Manager - Launch Strategy - Bio-Oncology 

This position is in the Managed Markets Launch Strategy group within Managed Care Marketing (MCM). MCM supports Genentech’s business by designing managed care marketing strategies, plans and tactics that enable Genentech’s goals to be met across US managed care segments (payers, channels, practices). Managed Markets Launch Strategy develops, implements and manages the managed markets marketing strategy, plan and tactics for Genentech’s pipeline. The team supports molecules as early as Phase II drug development, and involvement extends to approximately 6 months post-launch. Each Senior Product Manager has the opportunity to work on molecules at various stages of development.

Key activities for this role include:

• Representation of Managed Care Marketing in product launches. Builds, implements and manages the managed care marketing launch plans, including market readiness activities, launch readiness reviews, account segmentation, key message development, promotional development, field training, and competitive readiness (if relevant for pipeline products).  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. Creates and manages appropriate marketing budgets. Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Coordination of overall Managed Care and Customer Operations (MCCO) pre-launch activities. Leads MCCO launch team to drive cross-functional alignment and support creation of strategies, plans and activities that support optimal formulary positioning, reimbursement, access and overall market share. Provides managed care perspective to Brand and other partners, participates in Brand-led launch core team, launch readiness reviews, leadership updates, etc
• Strategic planning for relevant molecules to contribute to Phase III drug development investment decisions, trial design, and overall value proposition. 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. US and Global cross-functional partners include health economics, pricing & contracting, market planning, competitive intelligence and government affairs
• Expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans. Participation in US Commercial pipeline and launch teams as well as international payer strategy teams (IPSTs)
• Contribution to creating a center of excellence for launching new molecular entities (NMEs) and line extensions, where appropriate, in managed markets, by consolidating all pipeline activities into one group
• Compliance with all laws, regulations and policies that govern the conduct of GNE activities
  

Independently lead/participate on GMP compliance audits and identify GMP compliance gaps or risks. 

Provide GMP compliance expertise to internal and external customers.

Perform tasks and work to achieve company goals and organizational objectives.

·         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. 

·         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.

·         Perform any other tasks as requested by Management to support Quality oversight activities.

·         Participates in audits.  Lead audits.  Can develop audit findings that address individual gaps and system gaps.  Can lead all “low risk” and most “high risk” area audits.  Can participate on all high risk audits.  Report requires little or no input from manager.  May be asked to participate in meetings post audit to discuss unresolved issues with Senior Management.

·         Identifies gaps in corporate practices, policies and procedures and prioritizes based on current regulatory environment, guides and regulations.  Leads teams to remediate or defend identified risks.  Works with customers to develop CAPs and CAs for identified audit findings.  Presents information on outcomes to Sr. Management.

·         Will be assigned compliance opinions.  Needs no guidance from manager on resources / references. Opinion has depth and breadth and requires little or no input from Manager / review team.

·         Identifies gaps in corporate practices, policies and procedures.  Leads efforts to remediate gaps.  Write and or participate in corporate document development.

·         Participates in response development to regulatory inspection observations.  Author responses if assigned. Acts as a SME for GMPC.

·         Participates in FDA Meetings.  Acts as a SME for GMPC.

·         Participate as a GMPC representative in team meetings.  Is a SME on compliance issues. Independently raises compliance issues with the team.  Provides input on issues discussed informing manager of resolution. Communicates issues to manager as necessary.

·         Leads mock PAIs

·         Attends meetin...

This position may be filled at a Contract Manager  or Sr. 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 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 partners in field Account Management across MCCO Channel and Payer Field teams as well as GNE Government Affairs, 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
• As needed, supports field Account Management partners in negotiating contract terms and conditions
• 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
• Helps garner maximum return on investment and customer satisfaction from all contract responsibilities
• 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 Genentech activities
•  Business travel, by air or car, is required for regular internal and external business meetings
  

Product Manager / Sr. Product Manager – Managed Markets Launch Strategy, Growth Disorders

This position is in the Managed Markets Launch Strategy group within Managed Care Marketing (MCM). MCM supports Genentech’s business by designing managed care marketing strategies, plans and tactics that enable Genentech’s goals to be met across US managed care segments (payers, channels, practices). Managed Markets Launch Strategy develops, implements and manages the managed markets marketing strategy, plan and tactics for Genentech’s pipeline. The team supports molecules as early as Phase II drug development, and involvement extends to approximately 6 months post-launch.

PM/SPMs in the Managed Markets Launch Strategy group are generally responsible for multiple molecules at various stages of development. This opening would be primarily focused on leading launch preparations for a compound treating a growth disorder, which could represent a significant advance for patients.

Key activities for this role include:

• Execution of Managed Care Marketing deliverables for product launches. Builds, implements and manages the managed care marketing launch plans, including market readiness activities, launch readiness reviews, account segmentation, key message development, promotional development, field training, and competitive readiness (if relevant for pipeline products).  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. Creates and manages appropriate marketing budgets. Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Coordination of overall Managed Care and Customer Operations (MCCO) pre-launch activities. Leads MCCO launch team to drive cross-functional alignment and support creation of strategies, plans and activities that support optimal formulary positioning, reimbursement, access and overall market share. Provides managed care perspective to Brand and other partners, participates in Brand-led launch core team, launch readiness reviews, leadership updates, etc.
• Strategic planning for relevant molecules to contribute to Phase III drug development investment decisions, trial design, and overall value proposition. 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. US and Global cross-functional partners include brand marketing, health economics, pricing & contracting, market planning, competitive intelligence and government affairs
• Expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans. Participation in US Commercial pipeline and launch teams as well as international payer strategy teams (IPSTs)
• Contribution to creating a center of excellence for launching new molecular entities (NMEs) and line extensions, where appropriate, in managed markets, by consolidating all pipeline activities into one group
• Compliance with all laws, regulations and policies that govern the conduct of GNE activities
  

Contract Services Manager 

Contract Services Managers are responsible for contract services (including contract set-up, membership and affiliation assignment and maintenance) and/or customer payments in accordance with accuracy and compliance requirements. Customer payments may include responsibilities, as assigned, for processing fees, rebates, discounts and chargebacks, as per the terms of each contract. Additionally, Contract Services Managers act as subject matter experts (SMEs) on SPCM Contract Operations processes, collaborating with Contract Operations partners and stakeholders in various meetings, initiatives and projects. Expertise in the processes, calculations, systems and Standard Operating Procedures (SOPs) that support contract services and customer payments is critical to success in this position. Contract Services Managers, by comparison to Associate Contract Services Managers, also have responsibilities for developing complex analyses and reports, reviewing from the work of less experienced team members, performing contract set-up and structure for other team members, managing Internal Control Over Financial Reporting (ICFR) tracking and monitoring activities, and leading projects to improve processes and procedures.

• Acts as a lead SME for assigned contracts, other activities, SPCM Contract Operations systems, processes and SOPs
• Plays a lead role in cross-functional initiatives involving new/updated pricing and contracting strategies, terms, conditions, language and the like 
• Proactively seeks out complex information on changes in laws, regulations and other external factors and dynamics. Works with manager and other internal partners/stakeholders to interpret the information and assess its effect on current contracting models, pricing, discounts, rebates, chargebacks, compliance and the like. Develops appropriate responses, including recommending changes in complex pricing and contracting strategies, programs and contract administration
• Plays a lead role in development, education, communication, implementation and ongoing maintenance of Contract Operations SOPs, systems, processes, data, reporting templates and the like. Includes serving as a liaison for technology-related projects to ensure systems or enhancements are designed to meet the operational needs of Contract Operations and supporting testing for new or updated systems 
• Works with manager and others to establish appropriate performance metrics for monitoring, evaluating and reporting on contracts, contract performance and other business, legal and regulatory requirements
• Plays a lead role in development and delivery of Contract Operations training; including conducting training for other staff members and, as appropriate, others outside of the department
• As assigned, leads or otherwise participates in and supports other special projects
• As assigned, may perform some or all of the following:
• Enters contract information into departmental systems and databases Performs contract set-up and maintenance. Includes 340B Program Integrity support and assigning customers to appropriate contract groupings and class of trade (membership and affiliations), coordinating and managing contract term reviews
• Collaborates with other departments to determine appropriate pricing eligibility for new managed care customers; identifying customer entities, class of trade and appropriate contract pricing
• Implements departmental changes arising from such things as complex pricing strategies, updates to operating procedures, or internal policies affecting Contract Operations
• Uses relevant contract terms, conditions and other regulations, policies, etc. as well as appropriate systems and tools to evaluate, calculate, validate and process customer payments 
• Prepares payment packets as per the terms of each assigned contract. Ensures packets are routed through to all appropriate partners/stakeholders for review and approval
• Works with Customer Finance and other partners/stakeholders to track customer payments and ensure accurate and timely payments are made to customer accounts. Helping ensure penalties are avoided 
• Develops and evaluates contract performance using approved financial modeling templates
• Completes ICFR tracking and reporting, as per business and legal requirements and departmental policies & procedures
• Prepares, obtains approval for and ultimately publishes departmental scorecard reports, customer business review reports, various compliance and other ad hoc reports
• Performs ongoing membership and affiliate maintenance. May include updating membership/affiliation on an exception basis in accordance with business rules 
• Responds to questions/inquiries; may include policies, pricing, payment calculations, contract performance, complianc...

Department:   Site Services
Cost Center Name:  Site Engineering
Based on candidate experience the position can be either leveled as a Principal or a Senior Program Manager (E5/E4)

Responsibilities:

This position manages and directs a portfolio of construction projects <$10M at the Genentech South San Francisco campus (including Dixon and Redwood City). The program manager is the direct interface between an internal Genentech customer group and the Site Engineering outsourced project delivery service provider on each project within their portfolio and is accountable for the successful delivery of the entire portfolio while ensuring a high level of customer service.  The program manager role is strategic, customer facing, and leverages performance management principles to accomplish the work.  Key responsibilities include:

Customer Interface and Project Planning
The program manager is the direct interface between Site Engineering and the key representative(s) of a major Genentech functional group such as Research, PTD, Workplace Planning, Facility Operations & Maintenance, SSF Production, Energy Program and EH&S.  The program manager will be highly engaged with the customer to assist in developing new project scopes, providing input on initial costs and schedules for that customer’s portfolio of work (cLRP level estimates), and assist the customer in driving project starts.  To support this work in the Planning/Project Initiation stage, the program manager will engage resources as appropriate for constructability reviews, alternative analysis, scheduling, estimating, etc., to assist the customer in creating initial scope documents, which capture the initial scope, schedule, estimate, conceptual layoutsplans and key planning assumptions.  Service Level Agreements are developed and adhered to for the specific customer group.

Portfolio Management
The program manager will be responsible for the portfolio of projects executed for their customer group, overseeing all of the projects from planning stage to closeout and completion. The program manager will work with the project delivery service provider to assign projects to project managers from the service provider, and will be engaged with the status of each of these projects, providing input and strategic direction between them based on customer needs.  The cash flow and budget & resource management of the functional area’s portfolio shall be the responsibility of this role, as will assisting the customer in prioritizing their portfolio to meet available project resources. A key deliverable for the program manager will be the creation of a portfolio financial report, detailing the budget and cash flow status of the portfolio on a monthly basis.

Project Delivery
The basic function of this position is to ensure delivery of innovative and cost effective design and construction strategies for various construction projects at the Genentech South San Francisco campus (including Dixon and Redwood City) for each internal customer group.  The project portfolio consists of multiple small projects with total project costs up to $10M each. The typical program manager’s portfolio consists of 40-60 active projects at any given time, and totals approximately $12M-$20M of annual spend. The projects are delivered through a third party supplier who operates within the limits established by agreed upon scopes, budgets, and schedules of approved projects and makes decisions to control the work within these limitations.  The third party supplier executes projects through established project delivery processes, which includes key stakeholder engagement in defining project requirements and scope, business case justification, economic evaluations required to secure financial approval, and ensuring that projects meet intended functionality while controlling costs. The program manager works with the customer to define the project at a high level in the “Project Initiation” stage, and passes it to the project delivery service provider to initiate the project into the “Concept Design” stage, where the service provider takes over full responsibility of the project through completion.  The program manager oversees the work of the service provider with performance based / performance managed oversight.

Finally, a key role for the program manager is leadinggiving presentations to upper management to obtain funding for each project, usually in stages (i.e design phase funding, then construction phase funding). The service provider will prepare initialdraft presentation materials for the program manager, but final presentation creation and delivery to management is a key role of the position. The approving audience will consist of the Site Services Vice President and Directors. For proj...

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

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.  This role is focused on customer-specific pull-through through use of marketing tools and resources, including application of Value-based Healthcare, promotional, B2B, brand and other relevant resources for key accounts

• Acts as a key liaison to cross-segment MCCO (Managed Care & Customer Operations) account management teams and as MCCO liaison to relevant brand teams
• Consults and prioritizes with MCCO field leadership on most important accounts
• 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
• Works with various MCCO account management teams to develop and communicate the managed care marketing strategy for assigned managed care customer segments
• Provides strategic consultation to account management-led account planning
• Identifies and recommends account-tailored marketing opportunities
• Effectively and efficiently applies VBH, promotional, B2B, brand and other relevant resources to accounts, as appropriate 
• 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 wi...

MSL-Oncology

The states covered are Arizona, New Mexico, San Diego, Orange County, and Southern Nevada

Main Purpose of the Position:
The Genentech, Inc., Medical Science Liaison (MSL) functions as a field based member of the Medical Affairs organization. MSLs are scientifically trained professionals with strong clinical and / or scientific backgrounds. MSLs are expected to facilitate and implement the clinical strategies of Medical Affairs through:
* Relationship development
* Clinical trial support
* Scientific/clinical education and communication

Job Duties/Responsibilities:

General:
*Adhere to corporate compliance in all activities, including those related to clinical trials, scientific presentations, and responses to unsolicited requests for information.
*Maintain clinical, scientific, and technical expertise in specific therapeutic areas; review scientific journals, attend scientific and key technical meetings.
*Represent the Medical Affairs organization to investigator community
*Maintain ongoing long-term collaborative relationships with investigator and thought leader communities

Clinical trial support: MSLs interact with Genentech Medical Directors and their designees to determine and coordinate health care practitioner, researcher, and investigator activities.. MSLs act as the conduit between external customers and the Genentech Medical Directors.

Customer/Investigator support:
*Respond to and document unsolicited requests for information on our marketed products and products in clinical development
*Represent Genentech products at medical information exhibits during scientific symposia.
*Facilitate investigator and thought leader interactions with GNE Medical Directors

Commercial support:
*Provide internal clinical input and training to Commercial functions within regulatory guidelines
*Provide clinical and scientific support for Advisory Boards
*Content development/scientific review of content and presentation materials, upon request

We are recruiting for the position of Service Provider Strategy Lead to join our international Product Development Quality Assurance (PDQA) team.

Reporting to the Team Lead for Service Provider QA Strategy the ideal candidate will be responsible for the design and implementation of the Service Provider risk management and audit strategy across the GLP, GCP, GPVP areas. The role works in partnership with Procurement/Outsourcing Functions and the PDQA GLP, GCP, PV Strategy Leads to ensure that Risk Assessments are maintained across the inventory of Service Providers engaged globally (gRED, pRED, PD, GPS/gMED) and at Affiliate Level. 

This role monitors activities outsourced to Service Providers through periodic risk assessment, risk-based routine audits and provides ongoing support to mitigating actions. It also provides actionable data to Senior Procurement/Outsourcing functional management based on analysis of data (audit/inspection/risk) and identification of trends.

The ability to influence business partners in the area of service provider risk and quality management is essential to proactively identify and address issues with the skill to ensure that service provider quality issues are addressed in a timely manner and that the relevant management functions in the organizations are kept informed.
Key responsibilities and tasks:

• Design and implement the PDQA Service Provider risk-based strategy for risk management and audit activities
• Define/maintain the “audit/risk universe” of Service Providers based on input from Procurement/Outsourcing functions and PDQA GxP Strategy Leads
• Partner closely with the GxP Strategy Leads, Procurement/Outsourcing Functions to ensure that risk assessments are maintained for Service Providers to determine which audits will be conducted and where risk mitigation activities should occur. 
• Develop and implement a GxP risk based strategy to deliver an audit program and quality oversight model for service providers within service category areas. 
• Assess specific risk areas on an on-going basis, communicate to PDQA senior leadership and propose modifications to PDQA strategy where necessary 
• Develop and maintain risk assessment tools 
• Assess data/metrics from audits, inspections and risk management activities for compliance trends and risks 
• Develop communication tools (reports/dashboards) for audit and inspection metrics and trends
• Escalate significant compliance issues to PDQA Management
• Represent QA on Service Provider sourcing initiatives and Strategic Alliance or Category governance teams, participating in Service Provider due diligence visits where appropriate.
• Support regulatory authority GCP inspections at service providers.
• May lead or participate in GCP audits at service providers
• Provide leadership and direction to PDQ/PDQA and our customers/stakeholders on GxP related activities/issues related to Service Providers  
• Establish strong partnership/relationship with key stakeholders in Procurement and Outsourcing functions
• Review and provide feedback on service category area risk mitigation plans/CAPAs
• Provide quality leadership on complex issues (i.e., CHD) to Procurement/Outsourcing functions and PDQA staff
• Represent QA on Service Provider Strategic Alliance or Category Governance teams.
• Contribute to the development and execution of PDQA goals and initiatives
• Participate in or lead departmental or cross-functional compliance projects and initiatives as assigned
• Assists and/or contributes to the development and/or revision of PDQA SOPs, guidelines and tools
• Maintains knowledge of GLP, GCP, PV regulations and internal policies and SOPs  
• Maintains highest level of awareness and expertise in international GxP/PV regulatory requirements, guidelines, and policies, and applicable Roche/Service provider SOPs and project-specific procedures. 

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

3 positions available for locations in SSF. Washington DC or Basel

Main Purpose of the Position:

·        Provides objective and uniform assessments of quality and compliance risks across global network, including independent expert review of (1) the internal GMP auditing program and (2) correspondence to global health authorities regarding GMP issues.

·        Supports support liaisons and interactions with external bodies and committees to influence on technical quality issues through articles, speeches and participation on committees

Job Duties/Responsibilities:

·        Performs independent expert assessment to determine global uniformity and conformance to appropriate regulatory standards for (1) internal GMP audits and (2) correspondence to global health authorities regarding GMP issues, including written responses to inspectional observations.

·        Advise senior management across PT Global network on best practices, regulatory intelligence, key opportunities, and possible threats in the areas of quality and compliance. 

·        Provides up to date regulatory and compliance information and trends, specializing in specific regulatory authorities and regions, providing timely information to the PTQ organization.

·        Contributes to expert GMP compliance opinions for PT Global network, including Manufacturing, Quality, and Regulatory Affairs.

·        Participates as a key member of teams throughout the global Technical Operations Quality organization for strategy and policy, external interactions and influencing activities as they relate to Quality and GMP/GDP Compliance

·        Supports the overall efforts for strong health authority relationships in the areas of Quality and Compliance through effective communications, interactions and participation in meetings, conferences and committees with focus on respective region or area of expertise.

Crystallography Post Doctoral Fellow - Hymowitz Lab

Responsibilities:

A position is available for a postdoctoral fellow with expertise in crystallography to join the Department of Structural Biology at Genentech, Inc.  Active areas of research include the structure and function of intracellular signaling cascades involving ubiquitin as well as the structure and function of protein complexes relevant to human disease. The successful candidate will be involved in all aspects of crystallography, including expression and purification of proteins, crystallization, data collection, structure determination and analysis of protein structures.