Sr. Manager/Associate Director, Labeling Strategy Lead (Finance)

At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role

The Global Regulatory Labeling Strategy Senior Manager/Associate Director will be responsible for leading the development and maintenance of global labeling documents (e.g., Target Label, 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 Director, Labeling Strategy. The position will be based in our Princeton, New Jersey site which requires onsite presence 60% of the time per our hybrid policy.

Responsibilities

• Serve as the labeling subject matter expert responsible for advising Compound Development Teams (CDTs) and management on global labeling strategies based on Genmab's development programs, target product profile, and labeling and competitive precedence.
• Guide 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) for products registered in the EU, and their associated Patient Labeling Documents.
• Provide leadership in development of target labeling documents to support the design and analysis plan for clinical trials.
• Mentors and supports development of junior labeling team members
• Keep up to date with labeling guidelines and regulations as they relate to the development/maintenance of labeling documents and advise the LWG accordingly; assess impact on Genmab development programs.
• Advise LWG on the content of other labels in the same therapeutic class, including competitor labeling, to help the team in developing labeling text; monitor industry labeling trends and propose actions as appropriate
• Lead LWG throughout the process, from the decision to create or update a labeling document (CDS/USPI/SPC) through notification to stakeholders to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements.
• Ensure proper review, approval, implementation, maintenance, distribution and tracking of global labeling documents, including product labels, Target Product/Label Profile, CCDS for all Genmab products
• Prepares the 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, with PharmD/PhD/MD preferred.
• 4+ years of pharmaceutical industry experience, including 2 years Labeling (preferred) or related experience
• In-depth knowledge of current US and global regulations and guidance as they relate to overall global labeling
• Understanding of clinical development of novel biologics products, preferably in immune-oncology area

• Experience developing and managing labeling content for at least one major US submission (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
• Interest in developing junior team members

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

• Strong sensitivity for a multicultural/multinational environment
• Proficiency with MS-Office Suite and Adobe Acrobat application and ability to work in electronic document management system

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

Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.

When you work with us, you'll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website .

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 https://www.genmab.com/privacy .

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.