Senior Medical Writer, Pharmacovigilance

Your new company
Are you an experienced Senior Medical Writer looking for your next long-term contract opportunity?
I am currently partnering with a leading global pharmaceutical organisation seeking a Senior Medical Writer to join their clinical and regulatory writing team on an initial 12-month contract.
This role sits within a high-performing global team and will suit a writer who is confident leading the development of complex regulatory and safety documentation whilst collaborating with cross-functional stakeholders across Clinical Development, Pharmacovigilance, Regulatory Affairs, Biostatistics and Medical Affairs.

Your new role
Lead the preparation, review and delivery of high-quality clinical and regulatory documents.

Author and coordinate clinical study protocols and protocol amendments.

Develop Pharmacovigilance and aggregate safety reports including:

DSURs (Development Safety Update Reports)

PBRERs (Periodic Benefit-Risk Evaluation Reports)

Prepare clinical study reports, investigator brochures and other regulatory submissions as required.

Support documentation associated with medical devices and combination products, ensuring compliance with relevant regulatory requirements.

Collaborate with subject-matter experts to ensure scientific accuracy, consistency and timely delivery of documents.

Drive document strategy, standards and quality across multiple development programmes.

Ensure all documents meet global regulatory guidelines and company standards.

What you'll need to succeed
Significant experience working as a Medical Writer within the pharmaceutical, biotechnology, CRO or medical device sector.

Demonstrable experience authoring clinical study protocols.

Strong experience writing DSURs and PBRERs.

Medical device and/or combination product documentation experience.

Excellent understanding of regulatory requirements and industry guidelines, especially GVP

Experience managing multiple deliverables across complex development programmes.

Strong stakeholder management and communication skills.

Degree qualified in a life sciences discipline (advanced degree advantageous).

What you need to do now
If you are a Senior Medical Writer with strong protocol, DSUR, PBRER and medical device experience and are looking for a long-term contract with a highly respected pharmaceutical company, I'd be delighted to discuss the opportunity with you.

Click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on (phone number removed)

Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and must be based in the UK.