As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
Prepare, write, edit, and review high-quality, clearly-messaged documents founded in regulation and supported by the science for submission to regulatory agencies and health authorities. When necessary, serve as the RSW representative on project teams with the GRPT members, and functional area contributors (e.g., Clinical, Pharmacovigilance, CPPM, etc.) and other RSW staff.
Participate in project management for compound programs and/or RSW projects and initiatives. Ensure accurate and timely completion/delivery of information and review of regulatory submissions.
-Communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members. In pursuit of this responsibility the Senior Writer is to work closely with GRPT members on the strategic content of target documents.
-Understand, assimilate, and interpret sources of information (e.g., scientific literature, internal and external studies, research documentation, charts, graphs, and tables, and previous interactions with healthcare authorities) with appropriate guidance/direction from GRPT team and/or authors/key opinion leaders. Ensure required documentation is obtained. Explain and prepare data in a manner consistent with regulatory requirements. Confirm quality and completeness of information to be presented. Challenge conclusions when necessary. Convert relevant data and information into a form that meets regulatory document requirements. Ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines.
-Assist with the coordination of the review, approval, QC, and other activities involved in the production of regulatory documents. Assist in the arrangement and conduct of review meetings with the team. Resolve document content issues and questions arising during the writing process.
-Assist with regular communication with RSW leadership on timeline/milestone progress for any assigned program. Assess resource needs as timelines progress and communicate any additional resource requests to the manager.
-Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and SOPs.
-Assist in the design and implementation of tactical process improvements.
You are:
A Bachelors's degree is required with relevant medical writing experience, A Bachelor of Science is preferred, or Bachelor of Arts in English or Communications with significant relevant science experience. A relevant advanced degree (e.g., MS, PharmD, PhD, MD) is preferred, and higher education may substitute for years of experience. American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing.
Minimum of 7 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia, or in a related area such as quality, regulatory, clinical research, or product support/R&D.
High-level content writing experience and experience with clinical development regulatory documents preferred, with working knowledge of statistical concepts and techniques. Excellent written and oral communication skills. Capable of assimilating and interpreting scientific content with adeptness in ability to translate for appropriate audience. Excellent attention to detail and superior ability with respect to consistency, clarity and accuracy.
Knowledge of US and international regulations, requirements and guidance associated with regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
Knowledge of Common Technical Document content templates, electronic document management systems and information technology.
Excellent working knowledge of software programs in Windows environment.
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