Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.
Context
Within our Vaccines Division and integrated in a global team, we’re opening this a position as experienced medical writer who is able to take full responsibility for the writing of clinical documents and regulatory dossiers/including clinical protocols/study reports, Clinical Investigator Brochures, and more complex documents that are preferably not outsourced, such as INDs/IMPDs, Briefing Packages, PIP/PSP, Art.46 and CTDs.
Key Responsibilities
- He/She writes clinical documentation according to Company standards, international government regulations, and guidelines established by the ICH
- He/She presents clinical data objectively in a clear/concise format
- He/She provides scientific knowledge, analytical skills, and insight to Clinical Programs/Clinical Teams, and contributes to Submission Task Force meetings and cross-functional working groups as needed to facilitate the preparation of reports, and the production of registration dossiers always in a timely manner
Major Challenges
- The incumbent brings his/her strong expertise of Clinical/Regulatory writing and related activities to Clinical Programs and ensures the delivery of quality documents to support clinical trials and product registration. Document and submission strategies must be appropriately adapted to individual projects and specific regulatory requirements
- He/She needs a capacity to work independently with a global mindset and ability to collaborate across many interfaces and platforms
- Project timeline challenges may be encountered, which are solved within the context of the project team with input from the local Head of Medical Writing
Dimensions/Scope
- The Senior MW is responsible for making decisions for the documents he/she is responsible for that are aligned with company values, priorities, and SOPs, and with regulatory guidelines
- He/She is also responsible for proposing continuous improvements to standards and processes to improve overall efficiencies
- Major strategic and budgetary decisions must be discussed with the Head of Medical Writing
- Key internal and external relationships include Members of Study Teams (including Clinical Trial Leaders, Clinical Franchise Leaders, Clinical Trial Managers, Clinical Project leaders, Biostatisticians, Data Coordinators, Data Programmers and Project Directors), Regulatory Operations, Drug Safety Manager and Preclinical Product Expert. CROs and Co-development partners
Profile
Experience & Knowledge & Skills
- 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
- Background demonstrating fully acquired competencies in writing, editing, and reviewing all types of clinical documents and, possibly registration dossiers
- 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
- Excellent level of English, both verbal and writing
- Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills
Please provide your resume in PDF format and a motivation letter.
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.
As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.
