SENIOR REGULATORY MEDICAL WRITER, REMOTE
LOCATION
UK or select EU locations
EMPLOYMENT TYPE
Permanent
Full Time
Posting date: 15.04.2024
We have a great opportunity for an experienced Regulatory Medical Writer looking for a step up, or a Senior Medical Writer looking to move horizontally into a supportive, merit-based environment where a culture of collaboration and trust has been built over the years. Our client is a well-known CRO operating globally across many therapeutic areas. The Medical Writing function you will be joining has a large international team of writers, covering regulatory projects from early stage of development, through to marketing authorisation.
This role can be based remotely from the United Kingdom or most European countries. Get in touch for more information on locations.
What You Will Do
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Lead, author, and review a broad range of clinical and regulatory submission documents, ensuring accuracy, clarity, completeness, and compliance with established guidelines – CSRs, CSPs, amendments, IBs, subject narratives, safety documents, briefing documents, clinical sections of INDs, NDA/BLAs, MAAs.
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Perform internal document reviews, editing and Quality Control as needed.
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Manage and facilitate internal and client meetings. Coordinate cross-functional collaborations with key stakeholders. Represents medical writing in cross-functional teams.
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May participate in coaching and mentoring of junior team members.
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Participates in initiatives to improve medical writing standards and processes.
What We are Looking For
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Advanced degree in a scientific discipline is preferred (such as PhD, PharmD, or MD in life or health sciences), with 3+ years of regulatory medical writing experience in a pharmaceutical, biotechnology, CRO or other setting. Alternatively, a BSc with 5+ years of relevant experience.
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Experience as a primary author of regulatory documents, such as CSRs, Study Protocols, IBs, narratives, safety documents, briefing documents, CTA, IND/MAA modules.
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Ability to interpret and communicate complex scientific concepts in a variety of therapeutic areas.
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Excellent understanding of the drug development process and the regulatory guidelines in the US and the EU.
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Strong communicational, writing, grammatical, proofreading, and editorial skills.
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Demonstrated excellent presentation and project management skills.
What You Get in Return
In return, on offer is a competitive compensation package, flexibility and work-life balance, as well as opportunities for personal and professional growth in an international team dedicated to its people.
How to Apply
Get in touch with Oli Dimitrov for more information on oli.dimitrov@anttalent.com, on +44 208 135 5914, or click on the apply button to send us your CV or register your interest. We will be in touch as soon as possible.