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 JBRP1_UKTJ