Job Title: Senior Specialist (E4/5)

Job Responsibilities:

·         Key contributor for developing consistent strategies for stability studies performed at different sites, CMOs and partners

·         Manage and monitor milestones and detail timelines for assigned commercial products to ensure the achievement of corporate goals and objectives while providing timely and transparent communication to the PMT subteams and other cross-functional teams.

·         Provide scientific rational for stability study design and propose changes for the Genentech Quality organization

·         Provide scientific and technical leadership in Inspection/ Audit situations, thinking critically and acting creatively while providing information quickly and accurately

·         Author and  provide scientific as well as technical representation of Stability in all stability relevant sections for Submissions, Regulatory Agency responses, APRs and ARs

·         Work closely with other Senior Specialists and senior management to develop strategy for long range operational and resource planning   

·         Serve as a subject matter expert (SME) for stability questions related to assigned commercial products

Description Main Purpose of the Position:

• Direct Quality support staff and operations in accordance with cGMP regulations and Roche standards.
• Provide leadership and guidance to immediate staff hosting inspections or performing Quality Systems functions as assigned.
• Provide the Director, GQIM, with expertise in device and/or combination product inspection issues and risks.

Job Duties/Responsibilities:

• Optimize resources with the PTQS department.
• Interpret, execute and recommend improvements to Quality operational policies, plans and procedures.
• Provide input to department budget.
• Monitor and control expenditures against the department budget.
• Provide input for the development of overall Quality objectives and long-range goals.
• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Lead and participate in continuous improvement initiatives for Roche Quality Systems.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors described in Core, Common and Critical Competencies.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities. Technical

Duties/Responsibilities:

• Develop and oversee implementation of the Inspection Risk and Readiness systems to ensure on-going inspection readiness.
• Collaborate with Pharma Technical Operations and Quality areas as needed to identify inspection risks and mitigation plans.
• Serve as a GQIM primary point of contact and liaison for assigned sites
• Manage and oversee the inspection readiness program across sites to ensure proper deployment and reporting of inspection risks
• Lead or support regulatory inspections as appropriate.
• Collaborate with sites to develop and communicate inspection strategy, approach and goals.
• Communicate potential inspection risks and current state of inspection readiness to Senior Management.
• Provide input into the design and presentation of inspection readiness performance metrics
• Act as an advisor to internal project teams by providing extensive knowledge of regulatory requirements, industry standards, and company strategy.
• Attend and participate in external regulatory and/or compliance organizations, and applicable industry conferences to exchange information regarding current regulatory inspections and to stay current on inspection trends.

The Senior Finance Business Partner will support senior leaders in Technical Regulatory and Quality and Compliance (RQC).  Quality & Compliance, the broadest Functional Unit of the PT network, spans the Biologics, Small Molecule and Contract Manufacturing Operating Units.  As a business partner, you will contribute a business perspective as a member of the leadership teams and drive the planning, reporting and ad hoc financial analyses to support each of these leaders and their teams.  This position is focused on global controlling but has significant local controlling responsibilities, too.  The successful candidate will be seen by his/her business partners as a thought leader in financial issues and a “go to” person for financial / business advice. 

This position, based in South San Francisco, will report to the Head of Finance, Quality & Compliance and Technical Regulatory, located in Basel, Switzerland.

MAJOR RESPONSIBLITIES 
• As a contributing member of numerous leadership teams, provide business partner support to South San Francisco based Technical Regulatory and Quality & Compliance leaders and their respective global leadership teams. 
• Partner with RQC leadership to understand and seek new business drivers and key operational issues; actively identify tactical and strategic opportunities; contribute to the development of appropriate financial and performance metrics; recommend decision frameworks and present to senior management.
• Lead RQC global functions’ planning and forecasting exercises.
• Provide accurate and timely monthly management reporting.
• Provide decision-support analysis to management on projects and initiatives.  Leverage technical financial knowledge and available data to ensure analyses are well founded and thorough.
• Develop logic, models and presentation material for demonstrating/communicating value proposition for services provided by Regulatory, Quality & Compliance evaluating business need and significant changes within PT and Roche.
• Work closely with Accounting and Global FMT resources to ensure that RQC global functions’ financial and accounting data are accurate and aligned with principles governing technical operations including GAAP and IFRS (FGAR).
• Work with Capital Planning to ensure RQC needs are communicated and included in the Capital budget, forecast and business plan exercises.

The QA Product Technical Manager is the key point of contact for all issues affecting the disposition of their assigned product(s). This individual will be responsible for interacting with multiple departments within Roche to assure that all lot disposition issues are identified and resolved within standard lead times.
• Perform assigned tasks and work to achieve company goals and department objectives.
Job Duties/Responsibilities:
• Follow company policies and procedures.
• Maintain a state of inspection readiness.
• Provide input to the development of personal performance goals and departmental objectives.
• Collaborate with Management to establish and meet targets and timelines.
• Support routine operations and allocate assigned resources.
• Manage competing priorities.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Lead and participate in the design and implementation of department and cross-functional initiatives.
• Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult 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.
• Train personnel and internal customers on relevant business processes.
• 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.

Technical Duties/Responsibilities:
• Oversight of the activities associated with dispositioning of assigned production lots within established standard lead times.
• Management of lot disposition activities to ensure that products are dispositioned in accordance with regulatory requirements, cGMPs and Genentech policies and procedures, within established standard lead time.
• Interfacing with appropriate departments or manufacturing plants to ensure that lot disposition items are completed.
• Notification to Senior Management for all known delays in meeting established standard lead times or any potential significant quality issues.
• Interfacing with QA Lot Disposition Supervisors and Final Reviewers to ensure that final review activities are completed. Lead and provide guidance to Final Reviewers as required.
• Perform a review of investigations for potential cumulative effect to a batch history record.
• Perform a review of QC out of trend results for cumulative effect.
• Provide assistance to CMC teams by addressing lot disposition issues as they arise.
• Support regulatory inspections as needed.
• Assess batch history records as part of investigations into product complaints.
• Revise and approve applicable lot disposition documents as needed.

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...

Main Purpose of the Position:   
• Manage and develop solutions to complex global QC change control issues and Quality initiatives with inter-organizational and multi-site impact across the Biologics network following cGMP regulations and Roche 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. 
• Sign documents for activities as authorized and described by Roche policies, procedures and job descriptions.
• Be accountable for behaviors as described in Roche Leadership Competencies.
• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:
• Manage the end to end change control process.
• Manage multi-site change control activities for the Biologic OU including but not limited to; Specifications, direct materials, validated systems, methods, qualified equipment, and controlled documents.
• Manage the Review and approve processes for changes. 
• Ensure system and process changes are reflected in appropriate procedures and controlled documents.
• Collaborate with internal departments and across sites to ensure understanding and execution of change control process and procedures.
• Facilitate and contribute to cross-site change management forums. 
• Develop and implement strategies for effectively managing multi-site changes 
• Lead change control process improvement activities
• Promote and provide guidance in Good Documentation Practices.
• Assist in developing training content and qualifications for change control processes and change management applications. 
• Serve as a resource for Change Control knowledge management across site Quality departments.  
• Collaborate with Quality departments in the administration, access, and communication of the Change Control system.
• Manage Record Management and Record Retention program activities and processes.
• Manage the centralized records repository.
• Collaborate with Operational and Quality departments to maintain GMP records.
• Provide metrics and reporting as needed.

Manage selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.
• Ensure effective training program exists, improve with time, and are managed in compliance with PQS
• Ensure all employees have developmental goals and barriers removed to support attainment of goals
• Drive continuous improvement initiatives which simplify processes, enabling improvement in right-firtst-time, and appropriate prioritization of high compliance risks
• Manage and prioritize resources through IMPACT and in alignment with associated IMPACT prioritization priciples
• Ensure projects and initiatives are completed on time and within budget.
• Collaborate, influence and/or author department policies and procedures.
• At the cross-site and corporate level, provide leadership, vision and direction to:
­ address complex validation issues and influence network direction
­ develop and maintain validation programs  within cGMP regulations and the PQS.
• Monitor and control expenditures against the department budget.
• Immediately escalate potential quality or regulatory issues that may impact product quality or regulatory compliance.

Technical Duties/Responsibilities:
• Provide direction to subordinates in order to provide effective oversight of all validation systems lifecycle deliverables, per PQS.
• Interpret, implement and recommend improvements to validation policies, procedures, processes and workflows to meet quality and business objectives.
• Ensure that the Quality Leadership Team is aware of significant validation issues that may impact product quality or operations.
• Maintain and present validation systems health, representing the health of the program.
• Serve as technical and strategic resource for a range of validation assignments.
• Review and approve regulatory submissions and present validations to regulatory authorities during routine and pre-approval inspections.

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.

Job Summary:

Working in early clinical development at Genentech /Roche Inc gives the opportunity to provide translational safety contribution to projects combining good understanding and knowledge of toxicology and expertise in clinical safety and early clinical development, a very innovative approach where Genentech/Roche is a pioneer. 

Job Purpose: The Safety Science Leader (SSL) is accountable for all aspects of safety related to products in early development phase including single case assessment, aggregate reporting, integrated signal prediction/detection (ISP/ISD), integrated risk management process (ISMP) & comparative benefit/risk (in collaboration with Clinical and Regulatory) 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 to ensure that adequate safety measures are implemented based on data. ¿The Safety Science Leader maintains an Integrated Safety Management Plan (ISMP) throughout the life cycle of the product or medicine and is accountable for safety components of various documents including study protocol, study reports, development study reports. The Safety Science Leader represents Safety Science in Research and Early Development teams (RED teams) . She/ He supports and facilitates transition of projects from early to confirmatory development for all aspects pertinent to safety. 

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.

Job Purpose:  

The Head, Safety Sciences, leads and directs one of the therapeutic areas of safety science aligned with the Oncology disease to provide strategic direction and standardization of performance across the Safety Science groups.  

The Head, Safety Sciences directs Product Development Safety's (PDS) disease area specific scientific analysis including medical evaluation, risk assessment and management, signal prediction/detection, Comparative Benefit Risk, using epidemiology and other input as appropriate.  

The Head, Safety Sciences will ensure the incorporation of Comparative Benefit-Risk concepts in the disease area strategy and product plans and their use throughout the development and commercial lifecycle of products assigned to the cluster to ensure their longevity. In general, he/she is a member of a Development Review Committee (DRC).

Primary Responsibilities:

• Ensure proactive surveillance and monitoring activities across theirsafety science cluster to ensure that Roche is aware of potential emergingsafety issues and has developed strategies & action plans to prevent &mitigate risks.

• Direct and manage the SSLs andtheir teams within the safety science therapeutic area and provide guidance tothe relevant development and safety committees as appropriate.

• Maintain managerial oversight ofissues and outputs from the therapeutic area Safety Teams address or elevateissues to the PDS Global Head, Drug Safety Committee, Lifecycle Teams, Research and Early Development teams, and various committees.

• Ensure the incorporation of ComparativeBenefit-Risk concepts & qualitative/quantitative methods in the DiseaseArea (in collaboration with Clinical, Regulatory & Medical Affairs) andtheir use throughout the development and commercial lifecycle to ensure thesafety and longevity of all products in their therapeutic area.

• Leadcontinuous improvement efforts in Safety Science capability and performancetogether with the other Heads of Safety Science areas. Provide leadership and linemanagement to their reports and other members of the Safety Sciences departmentacross multiple locations. 

• Build andleverage Roche and PDS’ influence with internal and external entities to createvalue for Roche.

• Ensure Collaborative and constructive business relationships with majorpartners where applicable (with particular interest in Chugai).  Ensure particular emphasis is placed oncommunication flow and inter company.

• Contributes as part of the Global Leadership Team to the overallmanagement of the Safety Risk Management Department.

• Partners with Clinical Development organization to facilitate and collaborate towards the development of new oncology products proactively. Build strategic relationships with Clinical Development Oncology to drive innovative trial designs and influence decision-making.

Summary of Position:

The Clinical Safety Associate I (CSA I) assists in the clinical processing of adverse event (AE) information received by US Pharmacovigilance (USPV).  Responsibilities are performed under the direction of the USPV Manager. 

Job Duties/Responsibilities:

• Demonstrated knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements.
• Performs a review of ancillary documentation accompanying ICSR reports and identifies pertinent clinical information for incorporation into the case narrative.
• Performs Data Capture and Quality Review for all molecules and serves as a back up for additional projects.
• Identifies and initiates requests for case follow up for clinical trials and post marketing adverse events.
• Works with Submissions Team Responsible to properly identify US regulatory reporting requirements.
• Demonstrates a general understanding of appropriate labeling documents for assigned project(s).
• Demonstrates knowledge and understanding of safety exchange agreements (if applicable).
• Participates on Study Management Teams (as applicable)
• Assists in the development of drug safety presentation for investigator meeting presentations.
• Assists in clinical trial reconciliation process (as applicable).
• Organizes work load to ensure compliance with regulatory timelines for ICSR reporting.
• Ensures departmental workflow processes and timelines are followed. 

Competencies Identified for Success:

• Works effectively as a team member and promotes collaboration
• Demonstrates initiative and accountability
• Strong organizational skills, detail oriented, ability to adapt to change
• Confident decision maker

Position

Pharmacovigilance Programmer Analyst

Job Summary/Purpose:

Experienced Oracleprogrammer with good knowledge of Drug Safety databases.

• Assumes responsibility for the analysis of data from the Drug Safety Database (ARISg DataMart).
• Develops, tests, documents, maintains and validates programs written in SQL, PL/SQL and SAS.

Primary Job responsibilities:

The positionis within the Data Management Group (DMG). DMG is responsible for dataretrievals from the Drug Safety database. These retrievals are performed on adatabase named "ARISg DataMart", a databases that gets dailyincremental uploads from the ARISg transactional system. The DataMart isdesigned and optimized for data retrieval.

The maincustomers of DMG are the members of safety Science located in Basel,Switzerland, and San Francisco, CA. DMG performs data retrievals for ad-hocquery requests, aggregate reports and for signal detection. Currently all DMGmembers are located in Basel, Switzerland. The position is created to supportSafety Science on site in San Francisco.

Thefunctional requirements in detail are the following:

• Interactswith internal or external customers to clearly define the search criteriarelating to requests; and to aid in the selection of the appropriate dataanalysis strategy and adequate presentation of results.
• Checksresults of database retrievals for consistency and plausibility. Initiatesappropriate actions in case data inconsistencies are detected.
• Performs thestatistical analysis and presents data in appropriate format i.e., reports,line listings, tabulations or graphs through using a variety of tools like SQL,SAS, Excel.
• Ensurestimely and correct delivery of search results.
• Responsiblefor the documentation of the search strategy and the results (electronically oras hard copies). Ensures search strategies and results of searches are filedand archived.
• Assists inout-of-normal-office-hours ad hoc/special database searches in the event ofurgent enquiries or audits by regulatory authorities.
• Assumesresponsibility for signing validation documentation.
• Ensures anyissues relating to database searches are highlighted to the Head of PDS DataManagement Group.

GENERAL POSITION SUMMARY/PURPOSE:

Roche’s PDS organization is structured by product development phases, therapeutic areas and sites.  PDS enhances healthcare for patients by understanding and communicating the safety profile of Roche medicines to optimize their benefit-risk profile. Principal Safety Scientists in the Licensing and Early Development (LEAD) group supporting the Genentech Research and Early Development (gRED) organization will be responsible for the oversight of personnel and activities focusing on safety-related operational support of the early development teams within gRED. Principal Safety Scientists will be responsible for both the coordination of these activities and supervision of Clinical Safety Associates (CSA) within the LEAD-gRED group, and for individual contribution to these activities for a portion of the portfolio.  The Principal Safety Scientist will report to the Associate Head of LEAD-gRED Safety Science.

Cross-Functional Team Membership 

• Ensure appropriate coverage for all Protocol Execution Teams (PET/CPET) or Study Management Teams (SMT) for assigned molecules via supervision of CSAs and via individual contribution where needed.  Coordinate and liaise with the LEAD_gRED Associate Head and the gRED PET Leaders (PETL/CPETL) to ensure coverage of the necessary activities.  
• Proactively interface with gRED Protocol Execution Team Leader (PETL) to identify operational support needs for Safety Management Team (SMT) and/or Protocol Execution Team (PET) and prioritize coverage as needed
• Acts as single point of contact for CROs and affiliates with respect to safety operations activities
• Coordinate with PETLs to provide support to CRO regarding scope of work, requests for proposals, safety management plans, and kick-off activities

Product Development Safety-Related Operational Support for gRED early development teams

• Demonstrate advanced knowledge of safety reporting concepts, focused on standards set out in ICH and FDA guidelines for drug safety reporting requirements.
• Assists gRED Clinical Operations with ensuring appropriate inclusion of safety reporting information for investigator and site training; Independently performs clinical trial reconciliation (as applicable). 
• Review and address deviations in safety reporting sections of protocols vs protocol template; review and implement protocol specific reporting requirement e.g for Adverse Events of Special Interest; and ensure corresponding database and reporting processes are in place (e.g. IMP designation, appropriate listing of protocol in ARISg).
• Contributes to safety reporting sections of periodic reports (e.g. IND Annual Report, DSUR).
• Provide general assistance and expert input to the LEAD-gRED team members with the PDSS-PDSO interface. 

Process

• Demonstrate knowledge of requirements of clinical trial processes including CRO management, investigator and site training needs with respect to safety reporting, and safety data exchange agreements (SDEA).
• Coordinate SDEA process to ensure liaison between PET, PDSO representatives, and DSL members.
• Expected to play an advanced, expert role in PDS’s/PDSS’s policies, procedures, processes and other infrastructure developments.

Managerial activities

• As needed or otherwise appropriate, assists with recruitment, training, and/or coaching of new or less experienced PDSS staff members. 
• Ability to mentor and supervise CSAs.
• Define port-folio responsibilities for CSAs and set clear priorities.

Other

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of the LEAD-gRED early development safety organization to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned activities.
• Maintains the highest standards and levels of knowledge in the specific areas assigned.
• Completes and/or leads other special projects, as and when assigned, or otherwise requested.  Expected to contribute to PDS and PDSS beyond the bounds of his/her position and products; including leading and/or participating on cross-functional teams and work groups. 
• Provides additional support to his/her manager, and others, as needed. 
• Consistently complies with all governing laws, regulations, Roche SOPs and other guidelines.

Summary of Position:

The Clinical Safety Associate I (CSA I) assists in the clinical processing of adverse event (AE) information received by US Pharmacovigilance (USPV).  Responsibilities are performed under the direction of the USPV Manager. 

Job Duties/Responsibilities:

• Demonstrated knowledge of safety concepts, per ICH and FDA guidelines per drug safety reporting requirements.
• Performs a review of ancillary documentation accompanying ICSR reports and identifies pertinent clinical information for incorporation into the case narrative.
• Performs Data Capture and Quality Review for all molecules and serves as a back up for additional projects.
• Identifies and initiates requests for case follow up for clinical trials and post marketing adverse events.
• Works with Submissions Team Responsible to properly identify US regulatory reporting requirements.
• Demonstrates a general understanding of appropriate labeling documents for assigned project(s).
• Demonstrates knowledge and understanding of safety exchange agreements (if applicable).
• Participates on Study Management Teams (as applicable)
• Assists in the development of drug safety presentation for investigator meeting presentations.
• Assists in clinical trial reconciliation process (as applicable).
• Organizes work load to ensure compliance with regulatory timelines for ICSR reporting.
• Ensures departmental workflow processes and timelines are followed. 

Competencies Identified for Success:

• Works effectively as a team member and promotes collaboration
• Demonstrates initiative and accountability
• Strong organizational skills, detail oriented, ability to adapt to change
• Confident decision maker

Genentech Partnering is seeking a Manager / Sr. Manager to join the Technologies Business Development Group. The Technologies Group executes strategic collaboration and licensing agreements to support therapeutic lead discovery and companion diagnostic development by Genentech.

Responsibilities will include working in close collaboration with internal scientific stakeholders to establish strategy and prioritization for accessing external technology platforms, defining key technology criteria, actively seeking out opportunities that meet criteria and coordinating due diligence activities.

The successful candidate will lead negotiations with prospective partners on behalf of Genentech, creating collaboration structures that align with scientific and business needs, and will be responsible for making deal recommendations to Genentech senior management.

The BD Manager / Sr. Manager will work extensively with scientists in Genentech’s Research and Development Sciences departments on technology assessments and due diligence and with colleagues in the Legal and Finance departments on deal structuring, financial valuations and contract negotiations.

This position will report to the Director, Head of the Technologies & Diagnostics Group in Genentech Partnering.

E4/E5

The purpose of the role is to provide high quality evaluation and sourcing of oncology, hematology, and tumor immunology opportunities.  This individual will also lead confidential due diligence evaluations and pursue BD licensing and partnership opportunities.

Job Duties/Responsibilities:

Responsible for screening potential oncology collaboration opportunities.

Lead more detailed diligence on selected high priority deals as part of diligence teams.

Provide effective liaison with Early Clinical Development.

Serve as a member of the Oncology Portfolio Committee.

Proactively source appropriate opportunities for GNE consideration from academic, literature, trade publications, meetings, etc.

Education of other BD professionals, including reviews of technical literature.

As appropriate, pursue BD licensing and partnership opportunities.

Description

Management Associate, U.S. Commercial Services

Reporting to the Head of U.S. Commercial Services, the Management

Associate will provide high-level administrative support to the Head and leadership team members of the U.S. Commercial Services department.

Job Description:

The Management Associate supports the assigned executive and team (as appropriate) with a variety of group administration and operational activities.

Example Duties and Responsibilities:

- Acts as the departmental "go-to-person" for general operational or administrative questions or Genentech policies U.S. Commercial Services guidelines or other inquiries. There is a strong emphasis on organization and proactive coordination of activities.  

- Complex calendar management including meeting scheduling and resolution of scheduling conflicts

- Frequent interaction and planning with executive-level assistants and their customers

- Manage, plan and execute on key project support for management team, including representing company to wide range of partners and outside vendors

- Provide general administrative and clerical support to all areas in U.S. Commercial Services, as required

- Participate, plan, coordinate and prioritize work within or across teams' in support of department projects and goals using independent judgment and initiative

- Attend and actively participate at staff level meetings as required, coordinate/publish agenda and meeting minutes

- Address problems and develop practical, thorough, and creative solutions 

- Independently create and deliver communications based on general instructions

- Generate, disseminate and maintain departmental documents and information

- Administer and contribute content for the department's communication platforms, including portals, newsletters, and announcements

- Coordinate, schedule and execute departmental off-sites, team meetings, and activities, including cross-functional meetings or events

- Manage deadlines related to business planning as well as other special projects

- Develop, implement and evaluate department work processes and procedures 

- Collaborate with Admin team to support complex projects and deadlines

- Proactively assess travel needs and plans and propose arrangements

- Coordinate, monitor and track department contracts and PO's

- Schedule candidates for open positions within the department 

- Actively participate in the on-boarding of new hires

- Exercise independent judgment and discretion of sensitive/confidential and proprietary 

information

- Actively participate in Global Pharma Procurement and Commercial activities

- Ensure compliance with Genentech policies and guidelines in all endeavor

• Perform business analysis activities to design, develop, and deploy solutions including projects, enhancements and upgrades for internal customers
• Analyze data processing problems related to gRED information and planning systems including the Planisware solution and the gRED portfolio analytics platform
• Lead and facilitate meetings with Director and VP level customers to determine organizational needs and requirements and develop solutions
• Manage 2–3 major projects of diverse scope across functional areas
• Create and/or assist with required project documentation practices such as user requirements, functional specifications and service level agreements
• Resolve technical and process incidents and problems according to Service Level Agreements
• Collaborate with internal support teams and external vendors to ensure and continuously improve system stability and optimal performance for deployed solutions

Sr. Manager, Promotional Services

Location:  San Francisco, CA

Job Description

1. Compliance, Knowledge & Skills

o Follows all laws, regulations and policies that govern the conduct of all activities. Is accountable for being fully knowledgeable of all relevant policies and for abiding by these

o Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals

o Asks questions when in doubt

o Demonstrates leadership among peers by consistent application and modeling of the appropriate compliance, behavior and conduct

o Where applicable, is required to obtain and maintain full proficiency and knowledge of disease state, product and other aspects or issues as provided for and mandated by the company

2.  Team Leadership & Development

o Sets short and long term goals, vision and strategy for the team

o Plans & implements an aligned team structure with clear roles & responsibilities and ensures the appointment/placement of appropriately skilled/qualified team members to meet the different needs/roles within the team

o Hires, develops and retains talent on the team; ensuring alignment of hiring in relation to team structure requirements to help fulfill/meet departmental plans and objectives both in the immediate sense and over time/building for the future

o Ensures direct reports are developed to expand their skills and abilities, as well as relevant product and surrounding marketplace knowledge

o Proactively manages team performance, giving direct, clear, open & honest feedback, as well as recognizing and rewarding successes. Ensures any indirect reports are also regularly appraised of performance feedback. Complies, and ensures the same for any indirect reports, with all company policies & procedures in terms of formal performance feedback & reviews

o Acts rapidly, appropriately, decisively and consistently in cases of observed or reported potential policy violations. Is guided by company policies and procedures

o Ensures team members have access to needed resources and information that will enable them to perform their roles/responsibilities to the best of their abilities. 

o Provides direction, coaching, feedback and guidance to help ensure the team meets or exceeds assigned goals and objectives

o Leads by example in developing personal technical and leadership skills and ensures team members participate in similar opportunities

3.  Planning & Development

o Ensures team and self stay abreast of internal and external changes and evolutions: Genentech business strategies, goals and objectives, market and industry trends, as well as legal and regulatory developments and requirements

o Works with direct reports, brand teams across all Genentech Commercial business units, and external advertising agencies to proactively review and plan for upcoming promotional communication strategy requirements:

* Assigns team member responsibilities by Genentech business unit and/or Genentech brands

* Contributes to strategies around scope, content, order volume, artwork, quality, compliance and other project management direction, requirements and terms

* Plays a leadership role in managing external vendor selection process and programs

* Develops key content for all RFP documentation, including detailed requirements for promotional services as well as process for competitive bidding and selection

* Takes the lead departmental role in identifying and recommending opportunities to optimize their investment

* Ensures the team is meeting the needs of the commercial organization

o Responsible for ensuring streamlined departmental practices, procedures, systems and tools:

* Defines internal workflows and processes; includes development and implementation of DOPs (Department Operating Procedures) 

* Defines all roles and responsibilities across team

* Identifies, recommends and oversees the development of departmental systems and tracking tools, such as digital asset management system, gPrint, etc.

* Defines departmental performance metrics and standards, such as key performance indicators that enable the department and its internal customers to measure effectiveness and efficiencies

o Analyzes and makes recommendations regarding workload balance and required resources and other infrastructure needs to fulfill all project management responsibilities, goals and objectives across all Genentech business units

o Identifies, leads and/or assigns special, other departmental projects, as and when appropriate

o Leads the discovery process of new innovative solutions to the stakeholders that the team will take on as a priority 

4. Project Management & Operations

* Acts as lead industry expert for promotional communications stra...

The Procurement Manager is a vital role within the Pharma Procurement organization charged with building and maintaining a strong partnership with internal stakeholders. It is a leadership role in the development and execution of procurement strategies to maximize the value of the services procured for the US organization. This role is also responsible for Supplier Relationship Management, Process management and Customer relationship management.   This role is responsible for developing and demonstrating in-depth knowledge of markets, suppliers, products and their cost drivers within this category.  In addition, this role will be responsible for supplier relationship management and will lead cross-functional teams through strategic category sourcing to deliver breakthrough business benefits.

Key Responsibilities:

• Execute and implement professional services sourcing strategies for various Commercial groups. This position will require in-depth industry expertise in one or more of the following categories of spend: consulting firms, market research companies, training and meeting logistics vendors. 

• Demonstrate consultative behaviors with stakeholders so that this is the Procurement SPOC for the stakeholder

• Collaborate with stakeholders and key business units/partners to understand current procurement practices and use change management techniques to bring best procurement practices to the commercial groups  

• Provides end-to-end strategic solutions, from idea generation to presentation to senior business management and initiative execution

• Develop and maintain strategic relationships with key suppliers to ensure best service and commercial terms,  continuous improvement, innovation and optimal value are delivered to our commercial groups

• Achieve Annual Value Improvements through: 

o Tracking, monitoring and measuring key performance indicators for Supplier Relationship Management Programs

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

o Driving best practices and reductions in Total Cost of Ownership (TCO)

• Enhance and improve the tools and processes by capturing, sharing and evaluating best practices and lessons learned with Process Leadership

• Facilitate issues resolution when necessary

• Focus on the needs of the US organization while supporting the growth, demands and unique needs for our global organization

• Must be able to succeed in a non-mandated procurement environment 

• Must be able to lead in a cross-functional “matrixed” environment and proactively support internal customer requests

• Act as an ambassador for Commercial Procurement by demonstrating a collaborative and professional style