VACCINES - Senior Medical Writer - All Genders

<h1>About the job</h1><p></p><p>Our Team:</p><p>Join the French Medical Writing team (8 Medical Writers) in the Vaccine Clinical Department and work globally with the US Medical Writing team to coordinate and write the clinical documents and registration dossiers.</p><p></p><p>Main responsibilities:</p><p>This is a position for an experienced medical writer who is able to take full responsibility for the writing of clinical documents, including clinical protocols, clinical study reports, and Investigator Brochures and more complex regulatory dossiers such as INDs/CTAs, Briefing Packages, PIPs/PSPs, Art.46, and CTDs according to company and agency guidelines.</p><ul><li><p>He/she writes clinical documentation according to company guidelines and international government regulations and presents clinical data objectively in a clear, concise format.</p></li><li><p>He/she provides scientific knowledge, analytical skills, and insight to Clinical Teams, and contributes to Submission Task Force meetings and cross-functional working groups as needed to facilitate the preparation of clinical documents and registration dossiers.</p></li></ul><p></p><p></p><h1>About you</h1><p></p><p>Experience:</p><ul><li><p>At least 2 to 3 years of medical writing experience within a pharmaceutical company or clinical research organization (CRO).</p></li><li><p>Professional background documenting an excellent understanding of and experience in clinical development including clinical study performance/methodology/ basic statistics and/or the regulatory environment.</p></li><li><p>Knowledge of clinical development.</p></li></ul><p></p><p>Soft skills:</p><ul><li><p>Excellent interpersonal and leadership skills.</p></li><li><p>Ability to work both autonomously and collaboratively with transversal teams in a multicultural, multilingual, and geographically dispersed environment.</p></li><li><p>Must be deadline oriented, able to work under pressure and with a sense of urgency.</p></li><li><p>Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills.</p></li></ul><p></p><p>Technical skills:</p><p></p><p>            Mandatory:</p><ul><li><p>Ability to interpret clinical data clearly, accurately, and concisely to summarize and write clinical documentation, including complex submission-level regulatory documents in English.</p></li><li><p>Excellent word-processing skills and experience with electronic document templates are required and other relevant applications (eg, Excel, Outlook, EndNote, ReadCube, PleaseReview).</p></li></ul><p></p><p>             To be develop:</p><ul><li>Computer literate with proficiency in web-based/cloud-based document management systems (eg, Veeva Vault) and ability to learn new applications easily</li></ul><p></p><p>             Would be a plus:</p><ul><li>Knowledge of vaccine clinical development</li></ul><p></p><ul><li>Education: Advanced scientific degree, Master or PhD in life sciences, PharmD, or medically qualified is preferred.</li><li>Languages (Mandatory): Native English speaker or with proven excellent spoken and written English</li></ul><p></p><p></p><p>Pursue progress, discover extraordinary</p><p></p><p>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.</p><p>At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.</p><p>Watch our <a href="https://www.youtube.com/watch?v=SkpDBZ-CJKw&amp;t=67s" rel="noopener noreferrer" target="_blank">ALL IN video</a> and check out our Diversity Equity and Inclusion actions at <a href="https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness" rel="noopener noreferrer" target="_blank">sanofi.com</a>!</p><p></p><p></p><p>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.</p><p>As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.</p>