Senior Manager, Medical, Regulatory and Legal (MeRL)

Senior Manager, Medical, Regulatory and Legal (MeRL) Operations

At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off 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!

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.

For US based candidates, the proposed salary band for this position is as follows:

$132,480.00---$198,720.00

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.