Principal Medical Writer - Bio-Pharmaceutical

Details

  • Category: Pharmaceutical
  • Location: Lausanne area
  • Starting date: Jan 02, 2020
  • Domain of experience: Medical writing, drug development and regulatory requirements
  • Level required: Experienced
  • Years of experience: Minimum 7 years

Your Role

Within the Clinical R&D department, you will work as Principal Medical Writer in a candidate’s drug development context. This position involves the development of study-related documents, communication with health authorities, publications and presentations. One of the main missions will be to ensure compliance with international guidelines and internal quality standards.

Your Tasks

  • Develop, align and implement the European strategy and compliance
  • Develop the strategy for document preparation and document review processes
  • Collaborate closely with the teams in order to better understand the needs, the planning, and timelines
  • Write regulatory documents in collaboration with the regulatory core team member and other internal functions: Investigational Medicinal Product Dossiers, Investigational New Drug Applications, Briefing Books, Orphan Drug Designation application, Fast Track and Breakthrough designation requests, Pediatric Investigational Plans (EU and US) etc.
  • Write protocols/amendments, informed consent forms (ICFs), clinical study reports (CSRs), Investigator's Brochures (IBs)
  • Review work of other writers (contractors or internal functional area representatives) for accuracy, quality, focus, and adherence to format and stylistic requirements
  • Responsible for a timely document development and negotiating timelines with the Project/Study Team and the Medical Director
  • Develop the strategy for document preparation and the document review processes
  • Collaborate closely with the teams in order to better understand the needs, the planning, and timelines
  • Facilitate document review meetings and discussions

Your Profile

  • Master’s degree in a Life Sciences fields
  • Minimum 7 years of medical writing experience and/or other relevant pharma industry experience
  • Strong professional experience in drug development (early phase clinical development in Oncology) and regulatory requirements
  • Extensive knowledge of medical writing processes
  • Proven experience in writing regulatory documents for FDA and EMA
  • Proven experience in writing protocols, protocol amendments, briefing books, study reports, Health Authority responses, IBs, CSRs, ICFs
  • In-depth knowledge of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.) used for the preparation of clinical documents
  • Good command of English and solid writing/editorial skills (understandable, at a level appropriate to the audience and the project)
  • Strong ability to prioritize and manage multiple demands and projects with respect to deadlines
  • Ability to communicate scientific or medical information in a clear and concise manner
  • Self-starter, flexible, able to adapt quickly in a fast-moving environment, work efficiently within the given time and resources
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