Principal Medical Writer – FSP

🔥 4 minutes ago

🌐 United Kingdom, Ireland – Remote

🇬🇧 United Kingdom – Remote 🇮🇪 Ireland – Remote

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 10%

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ProPharma

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 2001

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 $8.6M Venture Round on 2020-10

Healthcare • Logistics • Manufacturing

ProPharma is a leading research consulting organization in the life sciences industry. The company specializes in providing custom solutions across the full product lifecycle, from early discovery to post-market monitoring. ProPharma's services include regulatory sciences, clinical research solutions, quality and compliance services, pharmacovigilance, medical information, and R&D technology. Known for its deep domain expertise, ProPharma assists clients in the pharmaceuticals, biotechnology, and medical device sectors with regulatory support, clinical development, and quality management. ProPharma's global team supports a wide range of therapeutic areas including oncology, cardiovascular, and rare diseases, among others, ensuring effective and efficient delivery of life-saving therapies.

📋 Description

• Author and edit high-quality clinical, safety, regulatory, device, diagnostics, and disclosure documents across clinical research phases and therapeutic areas • Manage clinical program documents including protocols, protocol amendments, IBs, ICFs, patient narratives, study reports, PBRERs, INDs, NDAs, BLAs, MAAs, and eCTD submission-level documents • Communicate project and program matters with medical writing leadership, functional area heads, internal resources, and consultants • Lead cross-functional coordination of resources and manage medical writing and QC deliverables • Supervise, train, and mentor less experienced medical writers • Manage client expectations, communicate directly with clients, lead project meetings, and manage deliverable timelines • Collaborate with clinical operations, data management, biostatistics, regulatory affairs, and other subject matter experts • Coordinate document QC reviews and maintain audit trails • Review statistical analysis plans and table, figure, and listing shells • Perform QC and peer reviews as required • Create and maintain timelines, update deliverable trackers, and host internal or client meetings • Maintain familiarity with industry practices, regulatory requirements, and medical writing guidelines • Manage budgets, workloads, multiple projects, and out-of-scope tasks • Participate in and lead departmental initiatives such as process improvement and lunch-and-learns

🎯 Requirements

• Bachelor’s degree or higher, preferably in medical or scientific discipline • Minimum of 5 years of experience writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics • Experience in a contract research organization, pharmaceutical company, or biotechnology company • Advanced knowledge of clinical research principles • Ability to interpret and present clinical data and complex information • Advanced understanding of FDA and other applicable regulatory bodies, regulations, and guidelines • Advanced understanding of regulatory submission requirements and processes • Computer technology proficiency and expert MS Word skills, including tables, graphs, and figures • Exceptional project management and communication skills • High attention to detail and quality • English language proficiency • Familiarity with American Medical Association (AMA) style • Experience in relationship building and strategic collaboration on key business accounts • Ability to identify concerns or inefficiencies and propose solutions • Exceptional time-management skills and ability to work independently and collaboratively

🏖️ Benefits

• Remote working support • Hybrid working encouraged for new hires based within a reasonably short commute of an office, as agreed with the manager • Equal Opportunity Employer workplace committed to diversity, equity, and inclusion