Labcorp Drug Development are seeking an accomplished Medical Writer to join our Clinical Pharmacology Services team in the Early Phase division. This is a full time and permanent, office-based position in Leeds or home-based anywhere in the U.K. The Lead Writer is independently responsible for the preparation of clinical study protocols, clinical study reports (CSRs) and other documents as needed for lower complexity studies.
Your duties will include but not be restricted to:
- Write and coordinate the development of protocols, CSRs or other clinical documents including those of a more complex nature.
- Provide support in development of submission level documents under guidance of senior staff.
- Oversees management and coordination of complex narrative projects.
- Produces scientific papers, abstracts and/or posters, and presentations.
- Responsible for all medical writing aspects of project development and coordination, adherence to timelines and budget.
- To prioritize and plan workload to a high standard. Effectively manage multiple assignments in parallel.
- Prepare documents in accordance with Labcorp Drug Development/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
- Review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
- Act as medical writing contact for major clients and partners.
- Keep up to date with developments in Medical Writing.
- In consultation with more experienced staff, show initiative and ability to deal with complex project situations.
- Inform management of medical writing problems promptly and propose solutions.
- Provide advice on Medical Writing issues to project team members (internal and external) and help to resolve problems.
- Contribute to Medical Writing initiatives to develop and improve processes.
- Mentor and provide guidance and training to other medical writing staff.
- Provide peer review and input on deliverables prepared by colleagues.
- Provides scientific leadership and support to colleagues in the data management and reporting team.
- Provide support for Business Development opportunities such as time and cost estimates, attendance at client bid defense meetings, industry conferences.
- Review Labcorp Drug Development SOPs and associated documents.
- Represent department in audits and inter-department working groups.
- Comply with Labcorp Drug Development internal processes and procedures.
Get ready to redefine what's possible and discover your extraordinary potential at Labcorp Drug Development. Here, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us and see why Labcorp Drug Development has been named by Forbes as one of the World's Best Employers 2020 and more than 90% of the top 20 global pharmaceutical companies are repeat customers. We can offer you not only a job, but a stable, long-term international career.Education/Qualifications:
- Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
- Recent and significant medical writing experience including two years as medical writing project lead.
- Excellent command of written and spoken English.
- Excellent written and verbal communication skills.
- In-depth knowledge of MS Word.
- Excellent organizational and time management ability.
- Detailed knowledge of ICH guidelines applicable to medical writing.
- Good understanding of medical/scientific terminology and experience in data analysis and interpretation.
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