Hobson Prior are seeking a Medical Writer to join a medium sized biopharmaceutical company on a permanent basis in Lausanne. This is an exciting opportunity to develop and review Study documents for Global Clinical Studies mainly for Oncology programs.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will be accountable to provide advice in the development and implementation of best practices in medical writing.
• Work together closely with internal specialists/colleagues/departments to obtain/provide information, ensure smooth review processes, incorporate editorial comments, and solve queries to present a 'finished' final document within the required deadline.
• Author and review clinical and regulatory documents such as Study Protocols, ICFs, CSRs, IBs, Paediatric Investigation Plans, Briefing Books, Requests of Product Specific Waivers, applications for Orphan Drug Designations, and responses to Health Authorities; the documents should be accurate, suited for the intended audience and easy to read.
• Review work of other writers (contractors or internal functional area representatives) for accuracy, quality, focus, and adherence to format and stylistic requirements.
• 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 - you collaborate closely with the teams to better understand the needs, the planning, and timelines & facilitate document review meetings and discussions.
• Trigger annual IB reviews and updates.
• Ensure understanding and implementation of international quality standards (ICH GCP) and internal company procedures.
• Facilitate document review meetings and discussions.
• Contribute to the development of project timelines.

Key Skills:

• You can prioritize and manage multiple demands and projects within deadline.
• Self-starter, flexible in adapting to changing circumstances or new information, able to adapt quickly in a fast-moving environment.
• Fluency in English and solid writing/editorial skills.
• Good command of MS Word.
• Good presentation skills and ability to interpret and present data in a logical manner.
• Attention to detail, accuracy, and logical organization. Expert grammatical and communication skills, both written and oral.

Requirements:

• Requires a master's degree, advanced Clinical/Science Degree is preferred (e.g. PhD, MD, etc.).
• A minimum of 5 years' experience supporting the development of Study Protocols, Protocol Amendments, Briefing Books, IBs, CSRs or ICFs in Pharmaceuticals.
• Robust experience of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.) used for the preparation of clinical documents.
• Robust working knowledge of the clinical drug development process, clinical trial design and biostatistics.
• Robust experience integrating information into clinical and regulatory documents.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.