Senior Manager, Medical, Regulatory and Legal (MeRL)
About The Position
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 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.
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.
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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
