Sanofi Group Director, Product Support Program and Market Research Governance and Effectiveness in Cambridge (U.S.), Massachusetts
Director, Product Support Program and Market Research Governance and Effectiveness
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Genzyme Corporation (a Sanofi company)and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
The Head of PSP & MR Governance and Effectiveness plays a critical role in supporting the business to provide patient programs and to generate insights through market research.They will collaborate and act as a liaison across the NA organization with program leads to provide oversight and lead Product Support Program (PSP) and Market Research (MR) governance and effectiveness efforts.These efforts are designed to ensure Sanofi Genzyme compliance to applicable legal and regulatory external and internal requirements, policies and guidelines particularly in the area of adverse event/pharmacovigilance requirements.
Role and Responsibilities:
Provide compliance oversight and support to the Sanofi Genzyme PSP & MR leads to ensure all programs/projects are conducted in alignment with regulatory and SOP requirements and documentation is maintained in an audit/inspection ready format.
Implement an integrated support approach to the PSP and MR leads by becoming a valued leadership team member in ensuring compliance with all applicable requirements.
Lead efforts and participate in various work streams in collaboration with the PSP/MR leads and to address gaps , ensure accurate inventory of programs, support ad hoc requests and drive overall process improvement.
Collaborate with PSP/MR leads to identify opportunities and recommend enhancements to applicable policies and procedures for continuous improvement as appropriate.
Act as the primary interface and liaison between PSP & MR leads and NA Quality, Sanofi Pharmacovigilance (USPV)/Global/Regeneron, Sanofi Genzyme Medical Information and PSP/MR, etc. to manage expectations and deliverables for programs and projects.
Lead Sanofi Genzyme PSP cross functional team meetings with NA Quality, Compliance, Legal, and Medical to align and harmonize approach for the PSP approval process and support leads in meeting approval requirements to ensure program timely approvals in alignment with the business and compliance needs and requirements.
Act as subject matter expert for PSP and MR projects to develop and implement SOPs and processes to drive compliant program implementation and ensure local processes are aligned with Global requirements.
Ensure audit and inspection readiness of all Sanofi Genzyme US PSP and MR programs and serve as subject matter expert during internal audits and regulatory inspections.
Provide oversight and guidance to the Sanofi Genzyme PSP and MR Leads especially in matters of training, service provider and vendor qualification and Pharmacovigilance AE reporting requirements.
Ensure PSP and MR leads maintain responsibility and compliance for all Adverse Event and Product Technical Complaint reporting, quality control checking and reconciliation as applicable.
Liaise with PSP leads to develop and report on metrics for Sanofi Genzyme scorecards and other key metrics as needed.
Lead and coordinate with PSP/MR leads any CAPA fulfillment requirements.
Maintain a full library of PSP and MR requirements
Serve as 4M/Zinc gatekeeper and administrator.
Communicate all new Global and US Pharma operations requirements to PSP and MR leads.
Participate in drafting and editing all new and current SOPs and work instructions with input from the PSP/MR leads as necessary and appropriate.
Drive sustainable required training efforts for all Sanofi Genzyme PSP and MR personnel in coordination with Sanofi NA Quality, Pharmacovigilance and Sanofi Genzyme PSP/MR leads.
Coordinate PSP and MR rosters and training reconciliation
Maintain version control of all appropriate training
Ensure Sanofi Genzyme training and compliance with applicable Global Quality Documents, US SOPs and relevant regulatory requirements through collaboration with PSP/MR leads and by ensuring PSP/MR lead accountability /responsibility for their programs.
Serve on the Global PSP & MR Program’s – PV Compliance Oversight Committee (P-COC) to ensure Sanofi Genzyme US interests are represented and clearly articulated as needed.
Bachelor’s Degree in Science or related field
Minimum 7 to 10 years in biopharmaceutical related industry
Experience and knowledge of commercial operations in the industry
Demonstrated leadership/management experience and good collaboration/influencing skills.
Understanding of Patient Support Programs and Call Center operations
General understanding of US Pharmacovigilance and DOJ/OIG compliance requirements (AE requirements). Knowledge of Global requirements a plus.
Experience and knowledge of Quality Systems SOPs
Experience with Training programs
Familiarity with electronic data management systems
Strong collaboration and influencing skills across multiple functions in a multicultural environment.
Excellent interpersonal, communication, presentation, negotiation and networking skills.
Analytical, forward thinker with good problems solving skills, sound judgment, goal focused, self-organized and self-starter
Ability to prioritize and cope with conflicting pressures and priorities
Awareness of the sensitive and confidential nature of information and/or situations
Fluent in verbal and written English
Primary Location: United States-Massachusetts-Cambridge (U.S.)
Job Posting: Oct 12, 2016, 9:43:03 AM
Job Type: Regular
Employee Status: Regular