Senior Medical Writing Manager

Hobson Prior are looking for a Senior Medical Writing Manager to join a top biotechnology organisation on a permanent basis in Stevenage. Our client concentrates on developing pioneering gene therapies to enable people living with chronic diseases live a better life.

Job Responsibilities:

• Responsible to utilise scientific knowledge and medical writing skills to effectively and clearly communicate technical medical plans and results.
• Provide internal medical writing expertise for the planning, authoring, review and approval of high-quality clinical and regulatory documents.
• You will ensure that medical writing deliverables are in accordance with regulations, standards, and guidelines.
• Contribute to process improvement activities including development and maintenance of medical writing standards & templates.
• Contribute to outsourcing strategy for medical writing deliverables.
• Deliver oversight for outsourced medical writing activities.
• Management of contracts and budget for outsourced medical writing.
• Provides input to submission plans, timelines, document content and dependencies.

Key Skills:

• Excellent oral and written communication skills.
• Collaborative working style with ability to partner across the organisation.
• Self-motivated and able to work independently.
• High-level technical and computer skills, and the ability to interpret complex clinical data.
• You can assess trends and patterns in text and statistical data, and effectively organizes content and messages in clinical reports and summary documents.

Requirements:

• Bachelor's degree or equivalent in the Life Sciences as a minimum.
• Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
• Proven track record in writing clinical and regulatory documents including, but not limited to protocols, clinical study reports, BLA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
• You will be familiar with approaches to expedite document preparation such as review tools and automation.
• Previous experience of vendor contracting, management and oversight.

Apply now:

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.