This position is for an entry level medical writer who is able to take responsibility for clinical study protocols, reports and Clinical Investigator Brochure updates with increasing levels of autonomy. He/she creates clinical documentation according to company guidelines and international government regulations and presents clinical data objectively in a clear, concise format. The incumbent must demonstrate competences in writing, editing, and reviewing clinical documents.
In this role, the Medical Writer:
· Works with project teams to prepare clinical and regulatory documents, including protocols, study reports, investigator brochures, INDs/IMPDs, and CTDs according to company and agency guidelines in order to support drug development.
· Contributes scientific knowledge, analytical skills, and insight to Clinical Scientific Operations, Project Team, and Submission Task Force meetings and to cross-functional working groups as needed to facilitate the preparation of reports, and the production of registration dossiers.
· Ensures a consistent style of presentation of clinical document to maintain quality and ease of review, and adherence to company standards.
· Works effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
· A scientific degree or Ph.D. in life sciences or PharmD is required along with 0-2 years of medical writing experience.
· Knowledge of clinical development processes is preferred.
· Background suggesting the ability to clearly, accurately, and concisely prepare all types of simple documentation in English, e.g. scientific authorship experience, editorial experience, etc.
· Experience as a Medical writer (preferably >3 years), or equivalent, or presenting relevant specialist qualifications (e.g., PhD). Knowledge of clinical development processes is preferred.
· Background documenting a basic understanding of, preferably also experience in basic statistics and experimental research.
· Excellent oral and written English.
· Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills.
· Ability to work autonomously and proactively.
· Possesses a sense of urgency and is deadline oriented.
· Works in an accurate, meticulous manner; is detail-oriented.
· Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills.
· Ability to work effectively in a multicultural, multilingual setting is required.
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.