Head of Medical Writing
il y a 1 semaine
ROLE:
Head of Medical WritingOur Director, Head of Medical Writing will be responsible for building Medical Writing capabilities in support of multiple clinical programs across all phases of development, including late-phase Biologics License Application (BLA) activities. The successful candidate will also be capable of playing a 'hands-on' role in the development and delivery of clinical and regulatory documents as needed. This position requires a highly motivated and enthusiastic professional with expertise throughout the product lifecycle. Key success factors for the position include a proven track record in overseeing Medical Writing teams and the delivery of high-quality submission-ready documents. In addition, this role requires creativity, integrity in thought and action, team-centric mindset, integrative thinking, ability to influence decision-making, exceptional communication skills, and the ability to inspire. This position reports to the VP, Clinical Operations.
MAIN RESPONSIBILITIES
Management, oversight, and operation of medical writing team responsible for development of clinical and regulatory documents. Candidate will be a player/coach. Advise on strategic document development, ensuring adherence to regulations, ICH guidelines, and standard operating procedures (SOPs).Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables using a mix of internal and external medical writers.Independently author, and manage others in creation of clear and concise submission-ready documents.Act as subject matter expert for development of data transparency deliverables.Develop and maintain SOPs, style guides, and quality control checklists that drive consistency across documents and processes.Build and mentor medical writing team.Represent Medical Writing in Inspection Readiness and participate in GCP Audits and Inspections.Plan strategically, anticipate problems, and recommend process improvements to address current and future needs. Build and ensure maintenance of knowledge base to improve the overall medical content of documents and ensure adherence to multinational regulatory standards. Establish systems and best-practices for training multidisciplinary colleagues participating in document authorship Lead cross-functional process improvement initiatives on document standards, template development, and document processes. Working knowledge of US FDA and European regulatory requirements. Extensive experience with IND and BLA packages, primary authorship of key components (i.e. CSRs) and mentorship of colleagues contributing to these submissions.Collaborate effectively across Clinical, Regulatory, Quality, Biostatistics, Data Management and CMC in a team environment.PROFESSIONAL EXPERIENCE/QUALIFICATIONS
Advanced degree in life sciences preferred; advance degree preferred; minimum BS/BA required; 12+ years' experience in a medical writing capacity within drug development, ON experience preferred.Prior direct experience leading medical writing teams responsible for all phases of drug development- submission experience highly desired. Extensive knowledge of English grammar and American Medical Association style guide.Demonstrated experience mentoring medical writers, managing project work of internal medical writers, and supervising external (contract/vendor) writers.Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines.Working knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory, and medical terminology.Proactive team player, collaborative, and flexible. Experience leading a team of Medical Writers.Ability to operate in a fast-paced, collaborative environment. Ability to perform work with a high degree of accuracy and quality while working under tight deadlines. Excellent verbal, written, and interpersonal communications skills with the ability to explain complex concepts with clarity and simplicity. Proficiency with Microsoft Office applications (Word, Excel, PowerPoint) and Adobe Acrobat Professional.OFFER
A stimulating position within a high-potential innovative biotech company.The opportunity to work in a science-driven, dynamic, respectful, and professional environment.A challenging scientific and business growth in which you get to bring your knowledge and skills.A permanent contract with an attractive salary package in line with the position responsibilities and your experience.-
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