Senior Medical Writer – Regulatory Writing – EMEA, Remote
Are you an experienced Medical Writer with extensive experience writing clinical study reports and protocols? Perhaps you are looking to broaden your regulatory writing experience across late phase studies? Want to join a global team, where you can develop your career and be involved in collaborative discussions on the drug development process, with other experienced Medical Writers?
The Senior Medical Writer will be responsible for the preparation and coordination of clinical study protocols and clinical study reports (CSRs), and other documents as needed, across global projects.
As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
- 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
Education / Qualifications
Degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
- Medical writing experience including, medical writing project lead experience, relating to clinical studies
- 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
Did you know?
In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.
We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com
Labcorp is proud to be an Equal Opportunity Employer:
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