Hays
Senior Medical Writer, Pharmacovigilance
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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.
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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).
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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 03330106292
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.
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