The Role

In this position, you are part of the Global Non-Clinical Safety (NCS) team and report to the Head of the Non-Clinical Safety team. As a key member of international, multidisciplinary project teams, you work closely with NCS Leads and are the lead author of nonclinical toxicology documents. This position can be based in our Princeton, NJ or Copenhagen, DK locations.

Responsibilities Represent NCS on global regulatory submissions project teams for Annual Reports, Briefing Books, Common Technical Documents, Safety Update Reports, Investigator’s Brochures, INDs, MAA, and NDA/sNDAs

Collaborate extensively with Global NCS team members to author, coordinate, monitor, review and/or approve the nonclinical responses to Heathy Authorities for pending applications

Expected to demonstrate an ability to work independently- producing high-quality documents with minimal supervision to meet timelines

Manage and coordinate the completion of documents within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes

Escalate issues when necessary to maintain project timelines and performance standards

Requirements MS in toxicology, pharmacology, or related field required. PhD is preferred.

At least 10 years of recent and relevant experience as a nonclinical writer of toxicology studies for biologics and/or pharmaceuticals.

Extensive experience with Acumen, DocuBridge, or similar regulatory document submissions tools

Strong project management, organizational, and communication skills (both written and verbal) to deliver clear updates on complex scientific information.

Solid understanding of regulatory guidelines and document management standards.

Speak and write in English fluently.

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

$,.00---$,.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: (k) Plan: % 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.