Job title: Periodic Reporting Expert Location: Morristown, NJ About the job At Sanofi, Patient Safety & Pharmacovigilance (PSPV) is at the forefront of protecting patients and optimizing the benefit-risk profile of our t…
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Michaels Stores
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Lead the cross-functional coordination of global periodic safety reports to ensure regulatory compliance and timely submissions. Serve as a subject matter expert while championing process improvements and mentoring team members on regulatory expectations.
Requirements
Requires a Bachelor's degree in a scientific field or a PharmD/HCP degree with relevant experience. Candidates must have at least 1-3 years of industry experience, including specific experience in pharmacovigilance and knowledge of ICH/GVP guidelines.
Full job description
Job title: Periodic Reporting Expert
Location: Morristown, NJ
About the job
At Sanofi, Patient Safety & Pharmacovigilance (PSPV) is at the forefront of protecting patients and optimizing the benefit-risk profile of our therapies. We leverage cutting-edge science, artificial intelligence, and global collaboration to ensure that every product we bring to market is safe, effective, and continuously monitored.
We are looking for a Periodic Reports Expert to join our Global Periodic Reports Team and play a critical role in ensuring regulatory compliance, driving scientific rigor, and communicating Sanofi's unwavering commitment to patient safety across the globe.
In this role, you will lead cross-functional collaboration with internal teams and external partners to deliver high-quality periodic safety reports that meet global regulatory standards. You'll have the opportunity to shape safety narratives, mentor colleagues and vendors, champion process improvements, and expand your expertise in a dynamic, international environment.
If you're passionate about patient safety, thrive in a fast-paced regulatory landscape, and want to make a tangible impact on the lives of millions, we'd love to hear from you.
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world and are supported and enhanced through our diverse portfolio of medical device and diagnostic products. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities:
Serve as a subject matter expert on global regulatory frameworks and pharmacovigilance practices impacting periodic safety reporting.
Lead the proactive, cross-functional coordination of global periodic safety reports (PSURs, PBRERs, DSURs) to ensure timely and compliant regulatory submissions.
Author and participate in health authority responses related to periodic reporting processes and content.
Champion continuous improvement initiatives that drive automation, efficiency, and quality across the periodic reporting lifecycle.
Provide mentorship and training on regulatory expectations and best practices to vendors, Sanofi collaborators, and global partners.
About you
Education:
Bachelor's degree (BS) in Biology, Chemistry, Biochemistry, Physics, or a related scientific field, OR
PharmD (Preferred), OR
Other Healthcare Professional (HCP) degree with relevant experience
Experience:
BS holders: Minimum of 3 years of industry experience, including at least 1 year in Pharmacovigilance, OR
PharmD holders and HCP: Minimum of 2 years of clinical or industry experience, including at least 1 year in Pharmacovigilance
Technical Skills:
Strong knowledge of ICH and GVP guidelines and their application to periodic safety reporting.
Proficiency in Microsoft Office and Sanofi applications (Viva, Workday, and standard Sanofi systems).
Soft Skills & Competencies:
Proven project management skills with the ability to manage multiple deliverables and competing timelines.
Flexibility and adaptability to navigate changing priorities and unexpected delays.
Comfortable leading cross-functional meetings in English with diverse, international teams.
Strong interpersonal and collaboration skills, with the ability to work productively in a multicultural, global 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.
Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.
#GD-SA #LI-SA #vhd
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.
North America Applicants Only
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, and additional benefits information can be found here.
We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth.
We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms
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How much do Management & Leadership jobs in Cambridge, MA pay?
Based on 949 listings with disclosed salaries, most management & leadership jobs in Cambridge, MA pay between $109k–$278k per year. Individual offers vary with seniority, company size, and specialization.
How many Management & Leadership jobs are open in Cambridge, MA right now?
There are currently 1,262 open management & leadership positions in Cambridge, MA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Management & Leadership roles in Cambridge, MA?
Companies currently hiring include Harvard Division of Medical Sciences, Sanofi, Biogen, Takeda, Alnylam Pharmaceuticals, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Management & Leadership jobs in Cambridge, MA?
Yes — 645 of the 1262 open management & leadership positions offer remote or hybrid work (79 remote, 566 hybrid).
How do I apply for Management & Leadership jobs in Cambridge, MA?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.