Senior Medical Writer
Our client is a global, clinical-stage biopharmaceutical company. They have asked us to assist them in their search for a Senior Medical Writer.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Plans, writes, edits, and reviews clinically focused regulatory documents. Such documents include among others, protocols, CSRs, ISS, patient narratives, briefing documents, Common Technical Document Module 2 clinical-focused documents and Module 5 integrated summaries, pediatric study plans, and Health Authority responses.
- Uses text, tables, and figures as appropriate to accurately and effectively convey key messages.
- Coordinates the production of high-quality clinical documentation (e.g. Clinical Study Reports and Summary Documents) prepared internally and by external vendors for submission to regulatory authorities in support of NDAs and global marketing applications.
- Alleviates any risks associated with medical writing and disclosure processes by generating and upholding Best Practices and SOPs.
- Safeguards document quality concerning agreed upon key messages, accordance with Standard Operating Procedures (SOPs) and Health Authority guidance, and consistency with applicable style guides and document conventions.
- Works with document authoring teams/Module sub-teams/Dossier Teams to establish document key messages, timelines, and priorities.
- Leads document kick-off meetings, partakes in timeline planning, and facilitates cross-functional document development as ad hoc member of Global Regulatory Project Teams.
- Manages review and approval workflows in the electronic document management system (EDMS).
- Develops processes and SOPs for Regulatory Writing.
- Offers input into resource forecasting for projects. Determines vendor requirements for Regulatory Writing needs and supervises vendors providing regulatory writing services when applicable.
- Provides guidance to project team members unfamiliar with or inexperienced in regulatory document requirements.
- Must have a minimum of 5 years of experience with medical writing/editing, publication management in the biotechnology or pharmaceutical industry.
- Experience in Infectious Diseases, Pulmonary Disorders, or related areas is preferred.
- Requires a Bachelor's degree in Life Sciences or related field, an MS, PharmD, PhD or MD is preferred.
- Must demonstrate a high-quality writing style in the English language and have the ability to independently analyze and synthesize data from a broad range of disciplines.
- Requires exceptional organizational and project planning skills.
- Must have strong interpersonal skills and the ability to relate and work in a cross-functional environment with a wide range of people to achieve results.
- Must be a self-starter with strong influential skills and be adaptable to change.
- Requires thorough knowledge of Good Publications Practices and thorough understanding of the Guidelines for Authorship of the International Congress of Medical Journal Editors.
- Must be familiar with style rules from the American Association Manual of Style, 10th Edition and creation, as well as the use of consort diagrams.
- Requires an understanding of regulatory requirements and ICH guidelines (including E3 and E6).
- Must have a basic knowledge of document management systems.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.