Job Purpose:

The Team Lead for CSV auditors in PDQA is responsible for recruitment, management and leadership of department audit staff.  Through their leadership and direction, they ensure consistent implementation of PDQA processes and procedures and execution of the audit strategy related to Computer System Validation

Primary Responsibilities and Accountabilities:

• Provide leadership and direction to the PDQA CSV audit team in the execution of the department strategy
• Recruit, manage, train and develop staff
• Motivates and manages team members through setting of individual goals, provides on-going feedback and performance evaluations
• Oversee staff expenditures
• Collaborate with other Team Leaders to resource and manage the audit program in line with PDQA Strategy 
• Manage resources according to department strategy
• Review staff deliverables (audit plans, audit reports, quality plans, etc)
• May participate on audits as necessary (staff evaluations)

• 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

• Supports Head of CSV Strategy and TL, Validation Analysts to establish and implement global CSV strategy, goals and objectives for team
• Participates on IT/CSV projects and task forces to provide quality management oversight

• Ensure consistent execution of PDQA strategy, processes and procedures
• Oversee execution of department strategy, processes and procedures
• Provide CSV compliance advice to staff 
• Ensure audits are conducted and reported in compliance with departments procedures
• Support regulatory authority inspections
• Escalate compliance issues/risks to PDQA Management
• Maintain knowledge of HR Corporate policies and procedures
• Maintain knowledge of current regulatory, GCP, GLP, CSV and/or PV regulations and guidelines and company policies, SOPs and procedure

There is an opportunity in the Technical Regulatory organization at Genentech at the Product Manager level.  This position requires use of regulatory and technical knowledge to develop, execute and oversee regulatory initiatives and strategies.  This individual will work with cross-functional project teams to develop regulatory strategy and ensure the success of regulatory filings through submission of high quality documents supporting the company’s development product portfolio.  Responsibilities will include accountability for IND, IMPD, and BLA/NDA/MAA applications as well as informational and pre-submission meetings with global health authorities, partners, and industry experts.  Additional responsibilities include leading departmental business process initiatives, and proactive communication with Regulatory and cross-function personnel and partners.  Candidates with a combination of broad technical, process and product development, and CMC regulatory experience are desired.

Position Purpose

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

Major Responsibilities and Accountabilities

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

• Is a standing member of the site and/or regional Regulatory Technology Leadership Team
• May lead the site or regional Regulatory Technology management team. Drives best practices and operational excellence within the department and cross-functionally and ensures timely communication and information dissemination across the department and beyond
• As needed, ensures appropriate appointment of staff members as ad hoc members in Regulatory Affairs Functional Teams (RAFT); driving and ensuring effective and efficient support for cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
• As assigned, self and staff may act as standing or ad hoc members of other teams for special or ongoing initiatives and projects

• Develops and manages annual and/or longer-range departmental budgets and resource plans
• Tracks departmental expense budgets to ensure compliance with agreed parameters
• Where applicable, self and team may participate in the negotiation with and commissioning of external vendor partners to support the work of Regulatory Technology
• Accountable for appropriate resourcing decisions for assigned Regulatory Technology function and staff
• Cascades strategic and other relevant goals and objectives as well as budget and other resources to direct reports
• Leads recruitment, hiring and on-boarding for his/her staff member positions. May include, as needed, short-term contract personnel
• Plays a lead role in creating and maintaining a positive work environment by encouraging mutual respect, innovation and accountability at all levels (global, site, functional, projects/programs)
• Ensures that performance of assigned Regulatory Technology management and staff is proactively managed and that management and staff are appropriately trained, developed and coached to maximize their contribution and ensure compliance with Roche and regulatory guidelines and standards. Accountable to ensure assigned management and staff consistently complete their deliverables and other responsibilities on-time, on-target and within-budget
• Conducts ongoing performance management and completes the required steps of Roche’s performance management process and cycle. Includes individual development plans/career discussions and actively contributing to performance calibration, talent management and succession planning processes
• Actively participates in management and skill development programs for continued professional development
• Leads routine and ad hoc meetings with assigned Regulatory Technology management and staff
• Identifies, recommends, assigns or otherwise undertakes special projects that further the success and effectiveness of Regulatory Technology and/or PDR overall
• As needed or otherwise appropriate, acts as a substitute for his/her manager in various meetings, communications or other forums
• Consistently complies...

Global Regulatory Leader

Accountable for regulatory management of a project(s) and leading a matrix team of regulatory professionals.

Primary Responsibilities and Accountabilities

• Accountable for global regulatory strategy and global regulatory deliverables for a PD project 
• Accountable for leading a matrix team of Regulatory Professionals, and for the RAFT deliverables.  Responsible for motivating and inspiring RAFT members
• Responsible for holding regular RAFT meetings, in accordance with RAFT guidance.
• Responsible for representing the regulatory function on cross-functional project teams (Lifecycle Teams).
• Responsible for representing the regulatory function on project specific matters to governance bodies
• Accountable for global regulatory Health Authority Interactions
• Accountable for managing decision-making, and conflict resolution surrounding regulatory issues within the Project Team and RAFT.  Responsible for ensuring appropriate escalation to functional management when necessary.
• Accountable for leading the RAFT on a PD project to:

• deliver strategic regulatory input to the lifecycle management of a project. 
• deliver specific guidance on regulatory issues such as legislation, guidelines, procedures to internal stakeholders (project team, regulatory function, governance bodies) 
• deliver integrated plans relating to regulatory submissions or specific functional projects 
• deliver regulatory submissions, in accordance with project timelines
• manage successful interactions with regulatory agencies and 
• analyse and landscape the regulatory environment for impact on the project and to brief internal stakeholders, as appropriate
• Responsible for sharing best practices within function to ensure efficiency and consistency across teams.
• Responsible for leading special regulatory projects/global process initiatives, as assigned.
• Responsible for acting as a change agent and role model within PDR by modeling best practices.

• Participates in site and/or regional and/or global PDR Program Management departmental meetings
• Participates as a standing member in the Regulatory Affairs Functional Team (RAFT) for assigned product development projects to help ensure effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough ¿and compliant execution
• As assigned or otherwise needed, assists relevant Regulatory Program Management Program Directors with their interactions, ¿communications and planning with various other teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams. Helps Regulatory Program Management Program Directors coordinate cross-functional PDR contributions to product development projects and other related activities
• As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics. Briefs teams and management, as appropriate
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
• Stays abreast of therapeutic area product development and other related business strategies and plans
• Supports on one or more regional projects at any one point in time 
• Analyzes data, the regulatory environment and business objectives to advise others on applicability of new or existing regulations and guidelines
• Participates in the development and implementation of the cross-functional regulatory strategy for each project or related assignment
• Supports Regulatory Program Management Program Directors in identifying and aligning cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
• Supports Regulatory Program Management Program Directors and others in preparing and facilitating meetings, teleconferences and other interactions/communications with regulatory authorities. Establishes effective working relationships internally and externally with regulatory authorities
• Documents meetings, teleconferences and other interactions/communications with regulatory authorities
• Supports Regulatory Program Management Program Directors in providing internal teams with direction on regulatory authority ¿interactions
• Participates in and supports management of ongoing RAFT meetings. Including providing ongoing guidance on regulatory ¿deliverables, compliance, timing and other relevant matters. Helps manage RAFT resources, including documenting meeting ¿minutes and conducting follow-up to ensure action items are completed in a timely and thorough manner
• Helps manage project plan...

In the position of Senior Regulatory Product Manager in Technical Regulatory Affairs, you will be accountable for the preparation of regulatory submissions and strategies supporting the product’s lifecycle and business needs.  This role within Pharma Technical Regulatory is focused on the development of strategies supporting biologic marketed products.  The successful candidate must have demonstrated leadership capabilities, a proven ability to work cross-functionally, and recognized strengths in collaboration, teamwork and communication.  He/She will be tasked to navigate and lead the preparation of complex global regulatory strategies with support from global team members representing both technical regulatory and various cross-functional representatives. The successful candidate must have an ability to develop and drive innovative solutions to complex regulatory strategies while maintaining compliance with regulations.  With a focus on biologics marketed products, he/she will also be required to provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management.  Additionally, he/she will support departmental business processes to document and improve best practices and work efficiencies.

He/she will be responsible for leading a team that delivers timely compilation and of all necessary documentation for regulatory submissions to support technical content of regulatory submissions. He/she will ensure quality; content and format of regulatory submissions comply with applicable regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics.

The successful candidate will be a key member of the Cross-Portfolio Governance (CPG) team within PPP/Pharma Portfolio Management. The CPG team establishes and manages governance operations and decision-making processes for late stage development to enable well informed and timely corporate decisions on portfolio investment and prioritization.

The manager of LSPC Operations works in close partnership with the late stage portfolio committee (LSPC) Business Manager and is responsible for providing project management support for CPG key initiatives and for leading and managing the monthly LSPC decision-making operations cycle.

Responsibilities

• Lead and manage the monthly LSPC agenda preparation process with key stakeholders in late stage teams in efficient, collaborative and transparent way
• Write minutes for the LSPC monthly meetings
• Anticipate, identify, manage and communicate risks to the execution of the monthly operations cycle
• Support LSPC Business Manager in preparing recommendations and proposals for meetings with LSPC Chairs and other senior leadership
• Maintain LSPC Charter, process documentation and required templates for team presentations for committee decisions
• Manage CPG communications with cross-functional stakeholders
• Guide, educate and support late stage teams, finance, PPM and other key stakeholders though the LSPC operational processes
• Actively contribute to best practices and continuous improvement
• Provide project management support to key projects, and programs led by CPG members and sponsored by senior leadership

Job Skills and Expectations

• Excellent project management skills
• A strong understanding of pharmaceutical/biotech industry, drug development process and trends, and business strategy
• Customer service orientation and attention to detail
• Strong oral and written communication skills
• Experience managing process improvement implementation and change
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.

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. 

• The Senior Regulatory Global Project Manager is expected to serve as a strategic partner with Global Regulatory Leaders (GRLs), work with the GRL and the cross-functional global filing team members to define regulatory filing strategy, convert the strategy into an executable plan, and facilitate flawless execution of the plan to enable successful global filings and Health Authority interactions;
• Applies project management methodology and disciplines to improve the efficiency and effectiveness of the global filing team;
• Contributes to the efforts of building templates, tools and processes to optimize filing team performance;
• Serves as business partner for the assigned TA (Therapeutic Area) in PDR, working closely with the TA Head, brings excellent project management service offering to the TAs, and also bring TAs’ request/feedback to the Regulatory Business Excellent (RBE) to help further optimize the performance and service offering by RBE.

• Provides appropriate level of Project Management service, and tactical leadership to multiple global filing teams based on the agreed scope of work and business need;
• Takes accountability for all project management aspects and works effectively and closely with the GRL or Team Leader;
• Drives creation and updates of a high quality filing timeline using MS Project with clearly defined activities, interdependencies, duration, task owners and planning assumptions; collaborates closely with the GRL and team members to coordinate, prioritize and aligns team’s activity in support of the project plan and ensure a structured approach to activity execution, and the efficient utilization of resources;
• Actively tracks the progress of the deliverables, and partners with GRL to create reports and trackers to ensure clear and transparent communication to key stakeholders;
• Works closely with team to identify and manage the activities which are on critical path and the critical activities that have the potential to become critical path activities; identifies the potential risks that could impact the timeline and PTS of a filing, and work with team to define a mitigation plan;    
• Effectively facilitates filing team meetings with high quality meeting agenda and minutes;
• Maintains an action item tracking log, drives the completion of the action items, and documents the resolution of the action items;
• Facilitates team communication, monitors the activities of the project team to ensure constructive team dynamics, effective communication and progress in conformance with project scope and timelines;
• Maintains proper online documentations of filing related project documents;
• Assists GRL on preparation, organizing and conducting lessons learned sessions post filing;
• Through support of the projects, identifies near-term improvement opportunities to leverage and/or enhance PDR PMO’s project management knowledge, process, tools, and templates to potentially increase efficiencies, accelerated activities and standardize processes.

As a product manager, you will be responsible for supporting the preparation, assembly, and review of both product and facility-related Chemistry Manufacturing and Controls (CMC) regulatory submissions.

The successful candidate must have broad regulatory and technical knowledge applied to develop, execute and provide oversight in the execution of complex regulatory initiatives and strategies.

The successful applicant will be required to apply practical scientific understanding of drug substance manufacturing facilities and knowledge of pharmaceutical manufacturing to facilitate the preparation and review of regulatory submissions and ensure compliance with applicable regulations and guidelines. The individual will lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities.  The candidate will support ex-US filings, as appropriate and as requested by corporate partners.  Additional responsibilities may include leading or participating in departmental operational excellence and business process initiatives.

Self-supervisory with senior management guidance on strategy. Exercises considerable latitude in determining objectives and approaches to assignments.

The Regulatory Manager must maintain a high level of professionalism, efficiency, and commitment. The successful candidate will demonstrate effective problem solving, strong understanding of regulatory affairs, excellent interpersonal skills and the ability to prioritize multiple tasks. Must have a proven ability to communicate effectively in both a written and verbal format. Ability to work both independently or collaboratively in a team structure. The incumbent will be interacting with FDA to facilitate timely review and approval of submissions.

Level : Associate Director

Technical Regulatory is a global function that supports strategic regulatory and submission activities for the Roche and Genentech product portfolio. Support of individual portfolio projects is managed through a Technical Regulatory Team, led by a Technical Regulatory Lead (TRL) who matrixes with other key development and commercial teams to ensure cross-functional alignment of strategy and execution.

An Associate Director level position is available for an individual to lead a TRT Program Management function that supports the Biologics Platform portfolio. Reporting to the Global Head of Technical Regulatory – Biologics, this individual will work with the Biologics Platform Leadership Team to establish expectations and competencies for TRTs and Technical Regulatory Leads (TRL) at all stages of development/commercialization. The TRT Program Management function will be responsible for TRL development and TRT training programs with support of project management resources and manage TRL talent development processes. In addition, the Associate Director of TRT Program Management will serve as an advisor to TRLs on matters of TRT project management expectations and logistics including those related to Health Authority and Affiliate interactions and planning, coordination and strategy of global filing and regional execution activities. This individual may also manage a small project management group to assist TRLs in project management and training on relevant PM. tools

Objectives and Scope of Position:

• Responsible for the preparation of regulatory documents for submission to regulatory authorities within subject area (clinical/safety). This role involves working in close partnership with the medical/scientific content owners in the relevant functions
• Takes accountability for delivering regulatory documents and works effectively and closely with key content owners 
• Applies document and project management expertise
• Contributes to the functional excellence of regulatory documentation (process management) 

Primary Responsibilities and Accountabilities

• Prepare regulatory documents in accordance with applicable regulatory guidelines/Roche standards/SOPs, ensuring high scientific quality & consistency with other documents where appropriate
• Liaise with document contributors to gather information (including Licensing partners where relevant)
• Plan & create timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate
• Review documents for: organisation/clarity/use of English language/grammar/scientific standards/consistency between textual presentations and listings/tabular or graphical displays 
• Manage the review process, including leading/coordinating adjudication of review comments and incorporating review comments
• Participate as a member of key functional/cross functional Team (s) (e.g. Regulatory Area Functional Team, Safety Team etc), ensuring that Teams adequately plan for document deliverables
• Ensure that the document is published in collaboration with Regulatory Operations and that the document is approved by the single accountable signatory

In addition as a Senior Regulatory Documentation Scientist

• Manage the preparation of a suite of regulatory documents e.g. Clinical Dossier, suite of Safety Documents
• Lead Writing Team for preparation of Clinical Dossiers/Safety Reports
• Review documents to ensure adherence to documentation quality standard, regulatory requirements and consistency of messages across all documents for a product/across clinical documents within a dossier
• Prepare specifications for outsourced work (writing/review of documents) and serves as Roche liaison for project purposes
• Plans and creates timelines for the production of assigned documents e.g. Clinical Dossier/Suite of Safety documents. Ensures proper planning and resourcing of all documents assigned to Writing Team including what work or portions of work to be outsourced
• Actively contributes to best practices and continuous improvement within Regulatory Documentation. Represents the group in functional and cross functional initiatives/projects when required

Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Program Directors are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Program Directors provide regulatory leadership for one or more regional or global development projects. Regulatory Program Management Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Program Directors are expected to lead more complex projects and represent PDR to cross-functional teams and groups with increased independence. Regulatory Program Management Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners.  Regulatory Program Management Program Directors serve as the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.

DUTIES & RESPONSIBILITIES:

• Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
• Provides regulatory expertise and leadership to site, regional or global cross-functional teams and other groups
• Stays abreast of therapeutic area product development and other related business strategies and plans 
• Serves as the primary PDR representative on one or more regional or global projects at any one point in time; typically complex projects
• Analyzes data, the regulatory environment and business objectives to recommend priorities
• Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment.  Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche
• Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development
• Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
• Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project
• Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management
• Serves as the site, regional or global principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site, regional and/or global teams
• Provides internal teams with direction on regulatory authority interactions
• Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters.  Manages RAFT resources
• Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made
• Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary 
• Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation
• Responsible to ensure all PDR deliverables associated with each project or other assignment are completed within defined timelines and...

Sr. Finance Manager – Pharma Finance Development (PFD), South San Francisco

Description:

The Pharma Finance Development group has ~ 45 people in multiple locations around the globe.  It is a cross-functional, cross-cultural group that supports the Roche Product Development organization.  This role is based in South San Francisco and reports directly to the Director of SSF Pharma Finance Development. 

The Senior Finance Manager is responsible for providing financial management and decision support to the Product Development organization. 

Major Responsibilities:
•   Provide local financial controlling support to several functions within Product Development (Biometrics, Portfolio Management, Global Medical Affairs, Quality)
•   Provide global controlling support in collaboration with global functional controller for Biometrics
•   Act as internal consultant by providing financial consultation and guidance to business partners as needed;  support business in understanding state of finances and actions required to achieve business objectives
•   Provide support for all budgets & forecasts for respective local and global functions supported throughout the year
•   Prepare and present monthly financial results to functional leadership
•   Participate and drive key strategic projects for PFD in support of Product Development
      o Provide strategic financial analytical support that both measures and drives efficiencies within the Development organization and improves decision making
      o Present analysis to PFDLT and the PDLT sub-functions
•   Collaborate with Global Controllers, Life Cycle Controllers and Global Development Heads on cross-functional projects and to ensure Product Developments meets its business objectives

Job Purpose:

The PDQA GCP TA Strategy Lead is responsible for the development and implementation of a GCP risk based strategy to deliver an audit program and quality oversight model for studies/products within a therapeutic area.  This role provides oversight to the PDQA program contacts to ensure consistent application of risk based strategy for each program within a TA, and provide actionable data to Therapeutic Area Senior PD management based on analysis of data (audit/inspection/risk) and identification of trends.  This role is to influence TAs in the area of risk and quality management so they can proactively identify and address issues.

Primary Responsibilities and Accountabilities:

• Design and implement a global GCP risk-based Strategy for audit and risk assessment activities for each program in a TA
• Develops and performs risk assessment strategy on each program in TA 
• Supports Program Contacts in risk assessment for each study in program and helps define PDQA priority studies list 
• Develop and maintain risk assessment tools
• Monitors risk data and recommends risk mitigation strategies to TA
• Oversee completion of TA and protocol specific Quality plans
• Input program specific information into risk assessments of internal processes and service providers
• Provide back-up support to all Program Contacts for a specific TA
• Assess and adjust the audit strategy for CTC audits (internal and compliance audits)
• Functions as an audit report reviewer for outsourced CTC Compliance audits
• Analyze data/metrics from audits, inspections and risk management activities for compliance trends and risks for all programs within a specific TA 
• Develop and deliver summary reports (audit/inspection/risk metrics and trends) to TA Leadership
• Provide compliance advice to the TA/product teams and PDQA staff
• May lead or participate in GCP audits for TA 
• Support inspection readiness and inspection management activities for products within a TA
• Support regulatory authority GCP inspections for products in Therapeutic Area

• Provides leadership and direction to PDQ/PDQA and our customers/stakeholders on GCP related activities/issues 
• Establish strong partnership/relationship with TA Senior PD Management
• Review and provide feedback on study risk mitigation plans/CAPAs 
• Escalate significant compliance issues to PDQA Management
• Support PDQ Partner Services in the implementation and oversight of QMS for PDG 
• Provide responses to GCP questions received from Compliance Help Desk for TA

• 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 highest level of awareness, expertise in international GCP regulations and internal policies and SOPs

The Regulatory Advisor will be responsible for developing global regulatory strategy, writing high quality dossier and leading teams for assigned projects to obtain timely approvals of Roche applications. The Roche Pharma Technical Regulatory leadership team is composed of seasoned technical experts whose focus is to collaborate with Roche Scientists and International Health Authorities to drive development of innovative regulatory policy, and ensure the approval of Roche products developed using novel and efficient process development strategies. This position will require regular interaction with management from multiple internal functional areas, corporate partners, international regulators and external experts.

The individual will lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities.  The candidate will support both US ex-US filings, as appropriate and as requested by corporate partners.  Additional responsibilities will include leading departmental operational excellence and business process initiatives, as well as, proactively communicate with Regulatory and cross functional personnel and partners in support of internal and partner associated goals.

The Regulatory Advisor must maintain a high level of professionalism, efficiency, and commitment. The successful candidate will demonstrate effective problem solving, strong understanding of regulatory affairs, excellent interpersonal skills and the ability to prioritize multiple tasks. Must have a proven ability to communicate effectively in both a written and verbal format. Ability to work both independently or collaboratively in a team structure. Have a proven ability to work well under pressure.  The incumbent will be skilled to lead communications with FDA and regulatory agencies to facilitate review and approval of submissions.

This position may be filled at a Manager, Analytics & Compliance - E4 or a Sr. Manager, Analytics & Compliance level - E5
 
Manager, Analytics & Compliance will support Government Pricing & Reporting (GP) teams and collaborate with key business partners, including other Strategic Pricing & Contract Management (SPCM) teams, Distribution Strategy, Government Affairs, Finance, Legal and Brand Marketing to deliver deep insights and actionable strategic and tactical recommendations that enable Genentech to rapidly and appropriately adapt to evolving U.S. government payer practices, policies, relevant legislation, regulations, trends and other dynamics . Frame and structure approach, research, analyze and synthesize information on the changing/evolving external landscape and internal strategic proposals for implications to government calculations, pricing and other related activities. Perform complex, strategic analysis of Medicaid, Medicare and VA/FSS data, including advanced forecasting, predictive analytics and trending, in order to proactively address current and future scenario planning, solve for “what if” type questions from stakeholders, and determine the impact of regulatory and other relevant changes.

Analytics & Compliance Managers play a leadership role representing Government Pricing & Reporting to cross-functional teams.

Analytics & Compliance Managers also play lead roles supporting GP Calculations and Medicaid Claims processes by advising on impacts of regulatory and other relevant changes to government payer claims and rebates and developing GP methodologies.

Acts as a subject matter expert and trainer on government payers and programs, as these relate to government pricing, contracting, administration, reporting and related matters.  Incumbents in the Manager/Senior Manager Analytics & Compliance role, as all other employees, are fully accountably for compliance with all laws, regulations and policies that govern the conduct of GNE activities.

Technical Skills: Actively Provide Strategic Support and Regulatory Impact Analyses to Relevant Business Partners [relevant business partners – see above description]

• Conducting Analyses & Scope and Structure Key Strategic Driver Business Questions. With some support and guidance from manager, assumes full accountability for asking questions of partner experts to seek deeper understanding of real drivers of decision-making and to identify core business questions. Proactively seek out complex information on changes in laws and regulations. With some support from manager, appropriately scope and structure projects, establishing a framework, key deliverables, and milestones in alignment with key stakeholders. Demonstrate ability to break complex problems down into distinct parts, simplify complexity, and manage uncertainty.
• Deriving Insights. With some support and guidance from manager provide strategic insights and recommendations to relevant partners by linking learnings across projects. Assess appropriate use of secondary research and internal data, leveraging internal expertise and resources as appropriate. Develops appropriate responses with supporting analytical justifications, including recommended changes in complex pricing and contracting strategies. Complement quantitative analyses with government payer and program knowledge to provide qualitative recommendations regarding potential implications or other impacts to Genentech’s business.
• Develop and Maintain Analysis Tools. Conducts quantitative analysis of government payer programs’ data to identify and provide data-driven insights and support government reserves forecasting; includes forecasting, trending and data mining. Maintain relevant data and information into respective departmental/company systems and databases to ensure current, accurate and robust analytics and reporting. Participates in the development, education, communication, implementation and ongoing maintenance of GP analytical methodologies and models, data and reporting templates.
• Presenting Results. Presents objective insights from analyses to relevant partners up to and including CLC. Produces and disseminates routine and ad hoc reporting to ensure GP and other cross-functional partners and stakeholders are kept fully abreast of key information relating to assigned government payers and programs. Creates and implements standard and ad hoc reports.
• Level of Expertise. Responsible for updating relevant government program methodologies and keeping these current at all times. Is knowledgeable in a variety of structured problem solving frameworks, market research methodologies, and excel forecasting techniques, and can apply them across business questions. Develops relationships and collaborates with relevant cross-functional partners to deliver respective subject matter expertise (see above j...

Sr. Product Manager

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

•  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

• 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

• Develops the Value-based Healthcare (VBH) strategy and tactics; including driving and shaping key customer partner initiatives in oncology

• 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

• Conducts field visits with key customers to review Genentech’s breadth of offerings

• Develops key VBH resources for MCCO (Managed Care & Customer Operations) field, collecting customer insights, creating tactics for case managers and training MCCO on resources

• Where applicable, supports product launches. May participate in the development and implementation of managed care marketing launch plans. Includes contributing managed care marketing expertise to other aspects of the overall launch plan and helping ensure launch plan excellence

• Works with cross-functional groups to ensure a seamless and well-integrated message and overall positioning across multiple marketing platforms, e.g., online, direct-to-patient, etc.

• Provides strategic consultation to brands and MCCO groups regarding key brand market events

• Creates appropriate marketing budgets by working with peers, manager and/or other internal partners

• Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility

• Continuously monitors and measures effectiveness and results from managed care marketing strategies, plans and objectives. Regularly reviews forecasting and other business analyses and uses to make appropriate further recommendations to increase market access, address currently unmet needs, and generally help to improve the overall market strength for Genentech in assigned managed care segments

• Directly manages the implementation of all assigned managed care marketing plans and tactics to ensure timely and quality execution that will meet or exceed assigned targets, goals and objectives

• Works with others to identify, recommend, create and help implement new account management tools/resources that will enable the field to represent Genentech in accordance with the defined strategy and position
  Complies with all laws, regulations and policies that govern the conduct of GNE activities