Senior Manager, Medical, Regulatory and Legal (MeRL)

Role At Genmab, we're building the operational capabilities that support the successful launch and commercialization of transformative therapies.We are seeking an experienced and forward‑thinking Senior Manager, Medical, Regulatory and Legal (MeRL) Operations, to help lead and evolve our promotional and scientific review ecosystem during an exciting period of growth.This is more than a process management role— it's an opportunity to influence how cross‑functional teams collaborate, drive operational excellence, and shape scalable review practices that enable timely, compliant communication with healthcare professionals and patients.The ideal candidate is a natural relationship builder, a continuous improvement champion, and a confident operator who can navigate complexity while keeping teams aligned and moving forward.This team member will bring a blend of launch experience, operational expertise, and systems knowledge, along with a passion for creating efficient, compliant, and scalable ways of working.This position reports to the Director of MeRL Operations within Genmab's Business Operations organization. Responsibilities Serve as the MeRL Operations brand lead for assigned therapeutic areas and promotional initiatives. Oversee the end‑to‑end flow of materials through the review workflow system in accordance with departmental Business Operating Procedures. Ensure timely and compliant submission, routing, review, and approval of promotional and scientific materials. Partner with project champions to develop and distribute review meeting agendas and coordinate workflow routing activities. Lead and facilitate Medical, Regulatory, and Legal review meetings, ensuring clear documentation of reviewer feedback and recommendations. Collaborate with MeRL Operations Editors to validate and reconcile reviewer comments and ensure accurate implementation of feedback. Build strong cross‑functional partnerships across Commercial, Medical Affairs, Regulatory, Legal, and external vendors/agencies. Drive the development and implementation of scalable MeRL review processes across strategic partnerships and collaborations. Coordinate appeals review meetings when necessary. Develop, maintain, and deliver training materials related to MeRL processes, systems, and operational best practices. Train internal stakeholders and external partners on workflow systems and review procedures. Partner with Regulatory Affairs to support preparation of electronic submission binders and materials for regulatory authorities. Continuously optimize and maintain the review workflow system to improve efficiency, transparency, and agility. Manage relationships with IT system counterparts and support ongoing system enhancements and issue resolution. Contribute to continuous improvement initiatives and share best practices across the MeRL Operations team. Requirements Bachelor's degree required Minimum of 7 years of pharmaceutical promotional review (MLR/MeRL operations) experience. Experience leading pharmaceutical product launches and label updates from an MLR/MeRL operations perspective. Demonstrated experience managing multiple complex projects in a fast‑paced, highly regulated environment. Ability to facilitate meetings with multiple stakeholders. Advanced proficiency with Veeva Vault PromoMats. Strong understanding of pharmaceutical promotional regulations, compliance standards, and submission requirements. Excellent communication, collaboration, and stakeholder management skills. Exceptional organizational skills with strong attention to detail and problem‑solving capabilities. Proven ability to work independently, prioritize effectively, and drive initiatives forward with minimal oversight. Proficiency in Microsoft Office Suite and related business applications. Experience working across partnerships, alliances, or co‑commercialization environments. Salary $132,480.00---$198,720.00 Benefits 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. #J-18808-Ljbffr