Director, Medical Writing

Role The Director, Medical Writing is responsible for advancing the medical writing portfolio within the clinical and regulatory areas. This includes authoring and overseeing the authoring of clinical documentation to support the conduct of trials and regulatory submissions/filings. The Director, Medical Writing participates in the development of templates and the establishment of medical writing processes and standards to ensure the quality and timeliness of regulatory filings and clinical documentation, in accordance with relevant regulatory guidelines and requirements. This role collaborates with the other members of the Medical Writing Leadership Team to manage the planning, oversight, and execution of the Medical Writing portfolio, drive strategic initiatives, and identify development areas within Medical Writing. Responsibilities Lead the planning and authoring of complex strategic clinical and regulatory documents, including clinical trial protocols, amendments, clinical study reports, and investigator’s brochures. Oversee the preparation of clinical overviews, summaries in CTD/eCTD format for regulatory submissions, Health Authority briefing books, responses, and scientific publications (abstracts, posters, slide presentations, and manuscripts). Represent medical writing on internal teams such as the Clinical Development Team and/or Clinical Trial Team, protocol review committee, regulatory submission teams, and ad-hoc working groups to support company initiatives. Independently lead cross-departmental submission teams, ensuring high performance standards and compliance with regulatory requirements. Mentor new employees and consultants and serve as a role model for junior writers. Guide medical writing staff during the planning and execution stages across all document types and regulatory submissions. Lead the development, review, implementation, and improvement of departmental processes, policies, standard operating procedures, training, and work guidance. Initiate and drive strategic Medical Writing initiatives and processes to ensure alignment with company priorities. Manage the oversight of Medical Writing vendors/CROs, ensuring high performance standards are met. Maintain up-to-date knowledge of relevant regulatory guidelines and requirements. Ensure adherence to guidelines, SOPs, practices, and technical standards in all aspects of work. Maintain current knowledge and competencies within relevant therapeutic and professional areas. Contribute to knowledge sharing, skill-building, and good collaboration with stakeholders and colleagues. Requirements Bachelor's degree in science or related area; Master's/advanced degree preferred 12+ years in clinical or regulatory medical writing in biotech/pharma industryor 15+ years of relevant, cumulative biotech/pharma industry experience with at least 10 years regulatory Medical Writing experience Oncology experience required Significant experience in writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA) Advanced familiarity with all phases of drug development and a clinical operations organization Significant experience in working with drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with all regulatory documents (including CTA/IND submissions, protocols, investigator brochures, and clinical study reports) Significant experience managing/guiding internal cross-functional teams Experience in managing a functional team/overseeing the work of other writers/CROs/vendors Proven performance in earlier role/comparable role For US based candidates, the proposed salary band for this position is as follows: $198,240.00---$297,360.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. #J-18808-Ljbffr Sonara Inc.