Director, Medical Writing at Genmab US, Inc.

Princeton, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Aug, 26

Salary

297360.0

Posted On

10 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Writing, Regulatory Submissions, Clinical Trial Protocols, Clinical Study Reports, Investigator's Brochures, CTD/eCTD Format, Oncology, GCP, NDA, BLA, MAA, Vendor Management, Cross-functional Leadership, Strategic Planning, Process Development, Regulatory Compliance

Industry

Biotechnology Research

Description

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! 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: Document Creation and Review: 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). Team Leadership and Collaboration: 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. Process Development: 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. Regulatory and Quality Adherence: 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. Professional Development: 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 industry or 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. When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com). Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract. Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

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Responsibilities

Lead the planning and authoring of complex strategic clinical and regulatory documents to support trials and filings. Oversee medical writing processes, manage vendors, and collaborate with cross-functional teams to ensure quality and timeliness of submissions.