Sanofi Group Scientific Advisor, NA Medical- Swiftwater/PA in Swiftwater, Pennsylvania
To provide scientific and medical input during the development and review of both promotional and medical non-promotional materials and represent Medical during the applicable Review Committees (RCs)
To assist in the development of both unbranded disease awareness and branded product-specific scientific and clinical content for slides and other materials to be used by office- and field-based Medical staff (e.g., scientific exchange, conferences, and other presentations)
To contribute to the development of safety documents and benefit/risk assessments for clinical and regulatory documents intended for submission to the US FDA and global health authorities (e.g., DSURs, PBRERs, study protocols, CSRs, and CTDs)
Be responsible, as a primary medical reviewer, for the medical/scientific accuracy and objectivity of Sanofi Pasteur US promotional materials, and ensure that information is current and accurate and presented with the appropriate context; all claims are substantiated by clinical and/or scientific data/references; and the information is consistent with appropriate medical practice, recommendations, and the established body of evidence.
Be responsible of the review and approval of non-promotional slides and other materials developed by office- and field-based Medical staff to ensure that the materials are aligned with scientific communication plans and are medically and scientifically accurate.
Review the medical content of SP-produced or -supported Internet websites and social media.
Actively participate as the Medical representative in regularly scheduled meetings of the Medical-Legal-Regulatory Review Committee (RC) and inform RC members of medical issues; providing solutions and alternatives where possible.
Advise and collaborate with internal and external business partners to ensure compliance with Sanofi Pasteur US scientific and medical standards.
Support the development of unbranded disease awareness and/or branded/product-specific scientific/clinical content (e.g., slide decks, publications, training materials, monographs) for engagement with and education of internal and external audiences.
Support Medical staff education on the cutting edge of emerging data, including literature reviews and reports of complex data from scientific literature, and present the data in an organized format.
In collaboration with the Medical Content Developer, provide guidance to Marketing and Medical items to ensure that all external and internal communication materials are aligned with scientific communication plans and are medically and scientifically accurate.
Represent office-based US medical during Safety Evaluation Team meetings.
In collaboration with Pharmacovigilance, contribute to the development of safety documents intended for submission to health authorities (eg, PBRERSs DSURs)
Draft f benefit/risk assessments (eg, structured benefit-risk assessments) for inclusion in study protocols, CSRs, and CTDs.
Participate in data review meetings of Medical Affairs sponsored studies.
Review literature published on SP products , in conjunction with PV, to identify information that might alter the benefit-risk profile of SP products.
Key Working Relationships
Regular, contact with:
US Medical Directors, Medical Science Liaisons, and other Medical staff
RC team members and coordinators
Commercial brand team members
Regulatory Affairs, Pharmacovigilance, and Legal staff
Regional Medical Strategy Project Manager
R&D and Clinical Development staff
Skills,Experience & Knowledge Requirements
Educated to degree level or equivalent with a scientific qualification. PhD, Pharm Ds, MD. A Masters of Public Health may be considered.
Prior vaccine experience is preferred
Experience (3+ years) in the pharmaceutical industry, preferably in Medical (global, regional, or local), clinical research, epidemiology, pharmacovigilance, medical writing, or regulatory affairs
Competent to critically appraise studies and clinical evidence
Knowledge of the pharmaceutical industry and of regulatory processes
Demonstrated ability as a proactive and effective team player with excellent verbal and written communication skills
Proven experience of building strong working relationships internally and externally to achieve results
Ability to collaborate and share information to contribute to the planning process and execute the agreed plan in line with objectives
Confidence in communication and interpersonal skills and hold a high standard of literacy and written communication
High attention to detail and accuracy as appropriate to the nature of the information handled in this role
An ability to prioritize work effectively; balancing both long- and short-term requirements
Fluent in English
Sanofi Inc. 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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.