- 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.
- 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.
- 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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Head of Medical Writing - Charleroi, België - iTeos Therapeutics
Beschrijving
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.
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