Director, Medical Writing

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Medical Writing in United States. This is a high-impact leadership opportunity for an experienced medical writing professional passionate about advancing innovative therapies in oncology and serious diseases. In this role, you will lead the development of complex clinical and regulatory documentation that supports global drug development programs and regulatory submissions. You’ll collaborate cross-functionally with clinical, regulatory, and scientific teams while shaping strategic medical writing initiatives and operational standards. The position offers a dynamic and science-driven environment where precision, collaboration, and innovation are highly valued. You will also mentor and guide writers across multiple programs while contributing to organizational excellence and regulatory success. This role is ideal for a strategic leader who thrives in fast-paced biotech settings and is motivated by meaningful patient impact. \n Accountabilities: Lead the planning, authoring, and review of complex clinical and regulatory documents, including protocols, amendments, clinical study reports, investigator brochures, and regulatory submission materials. Oversee the preparation of CTD/eCTD summaries, health authority briefing documents, scientific publications, manuscripts, posters, and presentations. Serve as a key medical writing representative on cross-functional development, regulatory, and submission teams, ensuring alignment with project objectives and regulatory expectations. Guide and mentor internal writers, consultants, and vendors while overseeing workload distribution, quality standards, and timely execution of deliverables. Drive the development and continuous improvement of medical writing processes, templates, SOPs, and operational best practices. Collaborate closely with leadership teams to support strategic initiatives, portfolio planning, and departmental growth. Ensure all documents comply with applicable regulatory requirements, Good Clinical Practice (GCP), and internal quality standards. Maintain current expertise in therapeutic areas, regulatory guidance, and industry best practices to support innovative and compliant documentation strategies. Requirements Bachelor’s degree in a scientific discipline required; advanced degree preferred. 12+ years of experience in clinical or regulatory medical writing within the biotech or pharmaceutical industry, or equivalent extensive industry experience with significant regulatory writing expertise. Strong oncology experience is required. Proven expertise leading the writing of major regulatory submission documents such as NDA, BLA, and MAA filings. Advanced understanding of clinical development, regulatory processes, GCP, and regulatory documentation standards. Demonstrated success managing cross-functional teams, external vendors, CROs, and medical writing contributors. Strong leadership, communication, organizational, and stakeholder management skills. Ability to work effectively in fast-paced, highly collaborative, and evolving environments. Experience developing operational processes, mentoring teams, and driving strategic initiatives within Medical Writing functions. High attention to detail with exceptional scientific writing and document management capabilities. Benefits Competitive salary range of approximately $198,240 – $297,360 annually, based on experience, skills, and location. Eligibility for discretionary bonuses and long-term incentive programs. Comprehensive medical, dental, and vision insurance plans. 401(k) plan with 100% company match on the first 6% of contributions. Paid vacation, sick leave, company holidays, and 12 weeks of paid parental leave. Wellness and support programs including emotional well-being resources, backup care, and financial wellness tools. Tuition reimbursement and lifestyle spending account. Flexible and agile remote working environment supporting work-life balance. Opportunity to work in an innovative, science-driven, and patient-focused organization dedicated to transforming cancer care. \n How Jobgether works We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process yo