Find & Apply For Clinical Analyst / Clinical Documentation and Improvement Specialist Jobs in Morristown, New Jersey

Periodic Reporting Expert Employer Sanofi Location Morristown, New Jersey Start date Sep 6, 2026 View more categories View less categories Discipline Administration , Training , Clinical , Drug Safety/Pharmacovigilance , Manufacturing & Production , Safety Required Education Bachelors Degree Position Type Full time Hotbed Pharm Country Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details 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 Sanofis mission where deep immunoscience meets bold, AI-powered research. In R D, youll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi:

Were an R D-driven, AI-powered biopharma company committed to improving peoples 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 peoples 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 its 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 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. Company Pursue Progress. Discover Extraordinary. Science has been our calling from the beginning. Sanofi's heritage of turning the impossible into the possible stretches back to the 19th century — a rich history of healthcare innovation built by diverse companies united by one shared purpose. More than 150 years later, that spirit lives in everything we do and every person we serve — from the patients who take our medicines, to the healthcare professionals who trust us, to the 83,000+ employees and communities around the world who make it all possible. And today, we're writing the next chapter of that legacy. We are an R D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Better is out there. Better medications, better outcomes, better science. And it all starts with people like you — from different backgrounds, in different locations, doing different roles — united by a single mission: we chase the miracles of science to improve people's lives. Take the most important step in your career and help us change the lives of patients, families, and communities for the better. Company info Location Cambridge Massachusetts United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Quality Assurance Specialist Milford, Massachusetts GRA CMC Specialist King of Prussia, PA Sr Associate Compliance Thousand Oaks, California