The Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development and maintenance of global labeling documents (e.g., Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and Intelligence. The position will be based in our Princeton, New Jersey site which requires onsite presence 60% of the time per our hybrid policy.

Responsibilities

• Lead the Labeling Working Group (LWG) to develop and maintain labeling documents  including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SmPC), and their associated Patient Labeling Documents.
• Serve as the labeling subject matter expert responsible for advising teams on global labeling strategies based on Genmab’s development programs, target product profile, and competitive labeling precedent.
• Act as Global Labeling Lead, supporting development, approval and maintenance of regional labeling (e.g., JPI)
• Manages new projects and projects of increased complexity including those involving 3rd party collaborators
• Keep up to date with global labeling guidelines and regulations as they relate to the development/maintenance of labeling documents and advise the LWG accordingly
• Advise LWG on the content of labels in the same therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labeling.
• Ensure proper development, review, approval, implementation, maintenance, distribution and tracking of labeling documents according to internal SOPs and external regulatory requirements.
• Prepares submission-ready labeling documents; Maintains and tracks labeling documents in the electronic system as appropriate.
• Participates in the development and maintenance of SOPs, work instructions, templates, and associated documents

Requirements

• Bachelor’s degree in a scientific discipline is required; PharmD/PhD preferred.
• 3-5 years of pharmaceutical industry experience preferred, including 2-3 years Labeling (preferred) or related experience
• In-depth knowledge of current US and global regulations and guidance as they relate to global labeling
• Understanding of clinical development of novel biologics products, preferably in oncology

• Experience developing and managing labeling content for at least one major submission (e.g., NDA/BLA), through negotiations and approval preferred
• Familiar with end-to-end labeling processes
• Ability to think strategically, communicate risks, and recommend course of action
• Self-starter with superior time management skills, ability to balance multiple tasks to meet priorities and timelines

• Ability to work independently or in teams. Ability to lead broad range of stakeholders at all levels internal and external to the company

• Strong attention to detail
• Effective communication skills, specifically excellent oral and written presentation skills.

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

$142,500.00---$237,500.00

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 bonuses.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed 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 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.