Principal Medical Writer

LausanneFixeChimie, Pharma, Biotechnologie2019-04-02Master / Université
We are recruiting, on behal of our client, an experienced Medical Writer on a permanent position.

Principal Medical Writer

Your Responsibilities

· Author documents such as protocols/amendments, informed consent forms (ICFs), clinical study reports (CSRs), Investigator's Brochures (IBs), briefing books, response documents, Paediatric Investigation Plans (PIPs). Manage review cycles, reconciliation of comments, and finalisation/approval of these documents.
· Review work of other writers (contractors or internal functional area representatives) for accuracy, quality, focus, and adherence to format and stylistic requirements.
· 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.
· Understand and implement the applicable international quality standards (ICH GCP) and company procedures.
· Provide expert advice in the development and implementation of best practices in medical writing.

Your Profile

· Minimum university life science degree or equivalent is required. Master's degree in a scientific area is preferred.
· 7 years medical writing experience and/or other relevant pharma industry experience combined with the knowledge of drug development and regulatory requirements, plus extensive knowledge of medical writing processes.
· Proven experience in writing protocols, protocol amendments, briefing books, study reports, Health Authority responses, IBs, CSRs, ICFs.
· Experience in early phase clinical development in Oncology.
· 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.
· Ability to interpret data, identify any limitations.
· Self-starter, flexible, able to adapt quickly in a fast-moving environment, work efficiently within the given time and resources.
· Ability to work with teams, establish trust, challenge appropriately and focus on re-sults.
· Ability to lead and influence.

Votre contact

Etes-vous intéressé(e)? Vous pouvez postuler soit en ligne, soit par eMail.

Merci de préciser la référence JN -042019-295454