This is a position for an experienced medical writer who is able to take full responsibility for the preparation of clinical documents and regulatory dossiers/ including clinical protocols/ study reports, Clinical Investigator Brochures, INDs/IMPDs, and CTDs according to company and agency guidelines. He/she creates clinical documentation according to company guidelines and international government regulations and presents clinical data objectively in a clear/ concise format. He/she provides scientific knowledge, analytical skills, and insight to the Clinical Teams and contributes to CTD Task Force meetings and cross-functional working groups as needed to facilitate the preparation of reports, and the production of registration dossiers.
The successful candidate will have a background demonstrating fully acquired competences in writing/ editing/ and reviewing all types of clinical documents including registration dossiers.
In addition the candidate ideally has the following qualities
- Good understanding of drug development/ clinical research/ study design, biostatistics, the regulatory environment/ and medical terminology.
- Detail-oriented with excellent interpersonal and communication skills.
- Ability to work both autonomously and collaboratively with a team in a multicultural, multilingual, and geographically dispersed environment.
- Possesses a sense of urgency and is deadline oriented.
- Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills.
- Native English speaker or with proven excellent spoken and written English.
- Possesses a solid work ethic, professionalism organizational ability and follow-up skills.
- Experience in immunology or vaccines is a plus
Education and /or Experienced Required
- Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified.
- Work experience of more than 3 years as a medical writer or equivalent, or presenting relevant specialist qualifications.
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.