Medical Writer

CDI

Full-time

Paris

Job description

This Medical Writer is responsible with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an integral part of the scientific management team, he/she/they ensures the quality, compliance with internal and external standards, and timely production of English & French documentation.

Responsibilities

  • Is responsible for the timely preparation and/or coordination, in English & French, of reports and/or related regulatory documentation (in some cases of extremely time-critical documentation), required for the planning, initiation, performance and reporting of clinical studies of our solutions.
  • Must provide dedicated scientific authoring expertise to ensure that the clinical opinion, as defined by the Chief Medical Officer, is presented accurately and concisely.
  • May need to liaise with external services and review documentation generated elsewhere (e.g. Clinical Research Organisations (CROs), subsidiaries, co-development partners), and internal support staff(e.g. for the preparation of tables, illustrations and appendices).

Qualifications

  • 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.
  • Experience as Lead Project MW on multiple types of clinical documents.
  • Professional background documenting an excellent understanding of, and experience in clinical development, including clinical study performance/methodology, basic statistics, and/or the regulatory environment.

Strong assets :

  • Knowledge of Digital Therapeutics and Digital Medicine.
  • Excellent interpersonal and leadership skills.
  • Ability to work both autonomously and collaboratively with transversal teams in a multicultural, multilingual, and geographically dispersed environment.
  • Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills.
  • English & French proficiency (Spoken and Written).