Principal Regulatory Writer

Fully Remote role

Job Summary
We are a specialty pharmaceutical company looking for a Principal Medical Writer to join our team as our first Medical Writer and partner closely with clinical and regulatory teams. The ideal candidate would have worked with a broad range of clinical documents. This role can be home based anywhere.

Job Overview
Who are we:
We are a specialty pharmaceutical company with both an established commercial portfolio and broad range of compounds going through development; including very positive phase II results. This role will require partnering closely with our clinical department and developing the medical writing function. Longer term we are looking to build out a team below this position.

Key Responsibilities

Responsible author of non-clinical and clinical documents Clinical Trial Application (CTA), Investigational Medicinal Product Dossier (IMPD), Product Specification File (PSF), Investigator Brochure (IB), Informed Consent Forms (ICF), Protocol Synopsis and Protocol, Trial Master File (TMF) and Clinical Study Report (CSR) and other supporting documents to support clinical development and/or marketed products as required

Assume responsibility for the quality of content of assigned documents

Liaise with other departments (including but not limited to non-clinical, Regulatory, CMC, Pharmacovigilance, Statistics, Data Management, Clinical Operations etc.) to develop, gather and synthesize input for the above-mentioned documents

To support with the identification and contracting of Medical Writing companies/resource and coordinate, review and edit their deliverables in cooperation with the project/study teams and provide medical writing and QC review support as needed

Continuous improvement in current company medical writing practices, define preferred medical writing standards, develop and maintain a departmental medical writing and document review policy and develop/update and maintain SOP(s) where needed

Skills Required

Key Skills:

Must have at least 5+ years of industry regulatory writing and clinical medical writing experience

The ideal candidate would hold a Bachelors, Masters, or PhD. in scientific, medical, clinical discipline

Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus

Understanding of clinical data

Exceptional writing skills are a must

Commutable locations: UK Home based

Salary: £70,000 - £85,000 + bonus

How to Apply: Please apply directly through this advert, reach out to Vivify Talent via our website (vivifytalent.com) or on +44 (0) 1223 080 457

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