An excellent opportunity has become available for a Principle Medical Writer to join an exciting Biopharma, based in Lausanne.
Within this role you will be involved with the development of study-related documents, communication with health authorities, publications and presentations. You will also ensure compliance with international guidelines and internal quality standards and is accountable for the process of authoring, as well as write concise documents.
*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.
*Provide leadership in cross-functional communication / team meetings to optimize feedback and input towards focused and high quality documents.
*Challenge and resolve conflict during document development and finalisation
*Drive process improvement and/or cross-functional initiatives (e.g., SOP review, template development).
*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.
*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.
*Self-starter, flexible, able to adapt quickly in a fast-moving environment, work efficiently within the given time and resources.
*Ability to lead and influence.
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email firstname.lastname@example.org