The primary responsibility of the Medical Writer is to work with the Sponsor’s cross-functional teams to understand the nature of the scientific work being conducted. The MW will assess data and products using their expertise, and develop expertise in new areas as needed. The Medical Writer will either generate or assist in the generation and/or quality control review of submission reporting documents in accordance with applicable procedures, protocol, regulatory, Sponsor-specific and GCP ICH guidelines.
The MW will:
• collaborate with clinical study teams, doctors, scientists, and other subject matter experts to create documents that effectively and clearly describe research results, product use, and other pertinent medical information.
• specialize in the writing, editing, reviewing and compilation of medical writing deliverables covering all phases of clinical research for submission to regulatory agencies and for Sponsor needs.
• ability to effectively handle conflict through proactive action, escalation and direct and timely communication.
• be a clear, concise, effective and skilled communicator with meticulous attention to detail and organizational skills.
• be curious and motivated, and work well independently or as part of a team in high-pressure situations while maintaining composure and professionalism.
• conduct comprehensive literature searches to enhance their background understanding and evaluate and analyze the information to be written.
• have the ability to manage requests from study teams and perform issue escalation.
The MW will have:
• demonstrated leadership and collaboration abilities.
• regulatory document writing experience needed for with the following deliverables: clinical study reports, protocols, investigators’ brochures, package inserts, informed consents, integrated summaries of safety, integrated summaries of efficacy, summaries of clinical pharmacology, summaries of biopharmaceutics, safety reports, patient narratives, briefing books, audit and regulatory agency report responses, and other documents for national and international studies/submissions.
• data interpretation skills to be able to review, interpret, analyze and present pharmacokinetic, pharmacology and efficacy and immunological data from complex clinical studies.
• regulatory document production experience to coordinate and integrate sections of regulatory documents produced by multiple departmental authors, including BLAs, NDAs, sNDAs and international submissions.
• the skills to be compliant with applicable company-provided templates, GCP guidelines, CTD and AMA standards.
• quality control (QC) experience to provide thorough review of submission documents produced by other authors.
• experience in creating SOPs, process documents, global policies, regulatory document templates, author guidance, and training materials.
• strong organizational and project management skills.
• Excellent interpersonal skills with demonstrated ability to work in a team environment and interact effectively with people at many levels of any organization.
The MW will have:
• preferred education: MS, PhD or PharmD degree in basic or applied science areas (or equivalent work experience).
• experience with MS Project, MS office Suite, Adobe Acrobat Professional.
• experience with Sponsor-specific document collaboration system (i.e. MasterControl, SharePoint, etc.) as required.
• expert knowledge of Regulatory requirements and ICH GCP guidelines.
• experience working with the Common Technical Document (CTD) format.
• an understanding of the levels of evidence required to achieve regulatory, marketing and regulatory goals.
• must be aware of current industry practices and regulatory requirements that affect medical writing and must keep abreast of current literature, emerging science, technological developments and medical trends.
• bonus: experience in preparing abstracts, scientific exhibits, posters and verbal presentations.
• bonus: experience in developing pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations to be used by a variety of audiences.