Senior Medical Writer

Hobson Prior are seeking a Senior Medical Writer to join a medium sized biopharmaceutical company on a permanent basis. For more information please get in touch!

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

Key Responsibilities:

• In this role, you will be responsible for reviewing work of other writers (contractors or internal functional area representatives) for accuracy, quality, focus, and adherence to format and stylistic requirements.
• You will drive process improvement and/or cross-functional initiatives (e.g., SOP review, template development).
• Author and review clinical and regulatory documents such as Study Protocols, ICFs, CSRs, IBs, Pediatric 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.
• 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.
• Provide advice in the development and implementation of best practices in medical writing.
• Trigger annual IB reviews and updates.
• Collaborate 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.
• 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:

• Ability to prioritise and manage numerous demands and projects within deadline.
• You have strong attention to detail, logical organisation skills and accuracy.
• Expert grammatical and communication skills, both written and oral.
• Great presentation skills and ability to interpret and present data in a logical manner.
• You are a self-starter, flexible in adapting to changing circumstances or new information and are able to adapt quickly in a fast-moving environment.

Requirements:

• The ideal candidate will have at least 5 years' experience supporting the development of Study Protocols, Protocol Amendments, Briefing Books, IBs, CSRs or ICFs in Pharmaceuticals.
• Strong experience of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.) used for the preparation of clinical documents.
• Strong working knowledge of the clinical drug development process, clinical trial design and biostatistics.
• Strong experience integrating information into clinical and regulatory documents.
• Good command of MS Word.
• Fluency in English and solid writing/editorial skills.

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.