Hobson Prior are seeking a Principal Medical Writer for a global biopharmaceutical company who are focused on the development and manufacture of drugs and diagnostics tools. This position involves the development of study-related documents, communication with health authorities, publications and presentations.
- Author documents such as protocols/amendments, informed consent forms, clinical study reports, Investigator's Brochures, briefing books, response documents, Paediatric Investigation Plans.
- Manage review cycles, reconciliation of comments, and finalisation/approval of these documents.
- Assess work of other writers for accuracy, quality, focus, and adherence to format and stylistic requirements.
- Develop effective collaborations with other line functions.
- Co-operate with Medical Directors to contribute to the strategy and understanding the clinical aspect of the writing and priorities.
- Offer 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.
- Develop the strategy for document preparation and the document review processes.
- Work closely with the teams to better understand the needs, the planning, and timelines. Facilitate document review meetings and discussions.
- Partake in resource planning for medical writing deliverables.
- Understand and implement the applicable international quality standards and company procedures.
- Strong English and writing/editorial skills (at a level appropriate to the audience and the project).
- Capable 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 and identify any limitations.
- Able to adapt quickly in a fast-moving environment, whilst working efficiently within given times.
- Able to lead and influence.
- Minimum university life science degree or equivalent is required (master’s degree in a scientific area would be preferred).
- A minimum of 7 years medical writing experience and/or other relevant pharma industry experience.
- Knowledge of drug development and regulatory requirements and medical writing processes.
- Proven involvement 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 preparing clinical documents.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.