Medical Writer, Early Phase
- Experience Level
- Experienced (non-manager)
Covance by Labcorp 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:
- Prepares protocols and CSRs, including interpretation of clinical data and statistical results as appropriate.
- Work under guidance from colleagues to assist development of protocols, CSRs and other clinical documents on complex studies and programs.
- Prepare and review patient safety narratives.
- Leads project management and coordination of narrative projects. Oversee and coordinate other writers on CSR appendices compilation.
- Prepare documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
- Participate in 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.
- Incorporates internal and/or external review comments on clinical documentation.
- Prioritize and forward plan workload to a high standard; to advise Management of problems promptly.
- Participate independently in internal and external client meetings. Lead meetings as appropriate.
- Responsible for project coordination and adherence to project timelines and budget.
- Identify ways to improve the efficiency and quality of work processes.
- Mentor Associate Medical Writers and Medical Writer I, as appropriate.
- Provide peer review and input on deliverables prepared by colleagues, as appropriate based on experience.
- Provide training to Medical Writers and other staff as appropriate.
- Represent department in audits and inter-department working groups.
- Comply with Covance internal processes and procedures.
Get ready to redefine what's possible and discover your extraordinary potential at Covance by Labcorp. 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 Covance by Labcorp 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.
- Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
- Recent and substantial medical writing experience including one year as medical writing project lead.
- Excellent command of written and spoken English.
- Good written and verbal communication skills.
- In-depth knowledge of MS Word.
- Good organizational and time management ability.
- Excellent interpersonal skills.
- Knowledge of ICH guidelines applicable to medical writing.
- Good understanding of medical/scientific terminology and experience in data analysis and interpretation.