Job Information
Sanofi Group Clinical Development Scientist, Neurology in Cambridge, Massachusetts
About the Job
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
The main purpose of the CDS job role is to collaborate with the physicians, assisting GPH, Clinical lead and CRDs in activities around the compound, MA interactions, support in literature reviews, and follow some development activities as post-commitment studies.
The new recruiter will work with a team composed of clinical development experts, statisticians, clinical operations personnel, medical writers, safety experts, regulatory affairs, medical affairs and external key opinion leaders. He/She will develop some medical competencies in the disease and experimental therapy for which he/she is responsible.
Job Responsibilities
Work with development physicians for the preparation of supportive documents for AdBoards and meetings with Regulatory Affairs
Literature review update related to external opportunities
Participates to the review of the list of countries for clinical studies and ensures alignment with Medical Affairs and Commercial teams on the business case for each country
Compiles regulatory, launch and reimbursement status in collaboration with regulatory, commercial and market access teams.
Collaboration and interaction with the Project Team members and the Project Leader and with the other departments of the Neurology TA (clinical pharmacology, Global Safety Officer, biostatistics, regulatory, Medical affairs and commercial teams) to facilitate the preparation of deliverables that need various contribution.
Contribute to the preparation of clinical sections of protocols, key result memo, clinical study reports, regulatory agency update reports, and other clinical and regulatory documents with focus on more routine/standard document elements describing all clinical procedures/ or studies to be included in this respective documents.
Participates to the review of scientific publications and communications to ensure data accuracy with source documentation such as CSR.
Provides support for the preparation of presentations used for different committees (BRAC, TARC, , , GPTM, STF, DWG...)
Participate at Global program level meetings, such as, , GPTM, , STF Requested Profile
Educational background : Scientific medical degree (PhD) with strong experience (>10 years) in Pharma business across different entities (R&D and Medical Affairs)
Experience in KOL interactions, in data review and interpretation, in manuscripts and abstracts preparation
Knowledge of Pharmacovigilance and CMC landscape, of project planning tools
Understanding of clinical research process from program planning to regulatory submission
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.
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.
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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.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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