Easter Seals Jobs

Job title : Global Labeling Strategist

Location: Bridgewater, NJ

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Global labeling BU Team as Labeling Strategist and you’ll be responsible for the labeling of a portfolio of marketed products and projects under development.

Main Responsibilities

• Support cross-functional teams as a labeling expert and contribute to the definition of global regulatory strategies and to the preparation of submission dossiers or responses to Health Authorities.

• Responsible for the maintenance and compliance of existing Marketing Authorizations (be a member of Response Teams within procedures such as European Arbitration/referrals, or work-sharing, PRAC questions (signal detection…)

• Prepare corporate labeling documents (Core Data Sheet or Core Safety Information), US and EU Summary of Product Characteristics and patient leaflet for projects and marketed products within the framework of regulatory submissions to obtain new Marketing Authorizations or to update existing Marketing Authorizations.

• Assessing development study reports, pharmacovigilance data (post-marketing), and any other scientific reports to take into account and manage regulatory requisites pertaining to labeling and implies interface with International Health Agencies.

This preparation requires:

• Lead a multidisciplinary labeling working group (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, Communication, preclinical and CMC…), the labeling working group is responsible for labeling proposals and the preparation of supportive documents and dossiers for labeling modifications:

• Coordinate the presentation of these proposals to the Senior Executive Management via a Labeling Review Committee.

• Support local countries in implementing labeling changes,

• Approve final proof of labeling artworks according to established responsibilities.

About You

*At this time, Sanofi will not sponsor a new applicant for employment authorization or offer any immigration related support for this position ( i.e. H1B, F-1 OPT, F-1 STEM OPT, F-1 CPT, J-1, TN, or another type of work authorization). *

Basic Requirements:

• ​Must be currently enrolled in 2023-2025 Sanofi PharmD Fellows Program

• Must have PharmD, PhD or similar degree (Physician, Pharmacist, Veterinarian or Life Sciences Degree)

• Practical experience in Regulatory Affairs, Pharmacovigilance, Medical Affairs or clinical development

Preferred qualifications:

• Knowledge of European regulations and international regulatory environment

• Excellent written and verbal communication skills

• Negotiation skills

• Demonstrated ability to solve problems and proactivity

• Ability to work with multifunctional and culturally diverse teams

• Organizational skills, ability to manage multiple projects at short notice.

• Excellent inter-personal skills

• Autonomy

• Fluent in English

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.

#GD-SA ​

#LI-SA

#LI-Onsite

#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.

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) !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

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)