Job title: Periodic Reporting Expert
- Location: Morristown, NJ / Cambridge, MA / Swiftwater, PA
Main responsibilities:- Expert on the global regulatory framework impacting global periodic reporting including the pharmacovigilance practices that impact the safety messaging of our products.
- Lead the proactive, cross-functional coordination of global periodic safety reports to ensure regulatory submission compliance.
- Participate and author health authority responses pertaining to global periodic reporting processes and content.
- Champion continuous improvement actions that drive automation, efficiency, and quality improvement.
- Provide mentorship and training on regulatory and process expectations to vendors, Sanofi collaborators, and global partners.
About YouEducation:
- Bachelor's degree (BS) in Biology, Chemistry, Biochemistry, Physics, or related scientific field with relevant experience, OR
- PharmD (Preferred), OR
- Other Healthcare Professional (HCP) degree with relevant experience
Experience:
- BS with a minimum of 4 years of industry experience and 2 years minimum of Pharmacovigilance experience OR
- PharmD with a minimum of 3 years of clinical or industry experience and 2 years minimum of Pharmacovigilance experience
Technical skills:
- Fluency in ICH and GVP guidelines.
- Proficiency in Microsoft and Sanofi applications (Viva, Workday, and/or standard Sanofi systems).
Soft skills:
- Proactive project management experience including multi-tasking of deliverables with competing timelines.
- Flexibility to adapt to changing priorities and delays.
- Comfortable leading cross-functional meetings in English.
- Strong interpersonal skills and the ability to collaborate productively in an international and multi-cultural environment.
Why Choose Us- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
The salary range for this position is:
$122.250,00 - $176.583,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
