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 Medical Writing Associate is responsible for supporting the medical writing portfolio within the clinical and regulatory areas by assisting in drafting and editing documents used to support clinical trial conduct and reporting.

The Medical Writing Associate follows medical writing processes and standards to ensure the quality and timeliness of clinical documentation, in accordance with relevant regulatory guidelines and requirements. Proactive engagement in departmental activities and initiatives to support the global organization is also expected.

Responsibilities

Document Support:

  - Assist in authoring clinical documents, including clinical trial protocols, investigator’s brochures, and clinical study reports.

  - Help draft and edit regulatory documents, including health authority briefing packages and responses, Pediatric Investigational Reports, and clinical CTD submission documents.

  - Provide editing support for clinical and regulatory documents as needed.

Team Collaboration:

  - Assist in facilitating trial team participation in document preparation, including scheduling meetings, developing timelines, and managing document reviews.

Process Development:

  - Participate in the review of standard processes and templates.

  - Support ongoing improvements in cross-functional and global collaboration, sharing best practices and knowledge.

Regulatory and Quality Adherence:

  - Adhere to guidelines, SOPs, practices, and technical standards in all aspects of work.

Professional Development:

  - Develop knowledge and competencies within relevant therapeutic and professional areas.

  - Contribute to knowledge sharing, skill-building, and efficient collaboration with stakeholders and colleagues.

Requirements
- High school diploma

- Thorough, systematic, and organized.

- Proactive, accountable, and goal-oriented.

- Innovative and a good team player.

- Excellent at sharing knowledge.

- Exceptional planning and coordinating abilities.

- Ability to manage multiple tasks simultaneously.

- Extensive knowledge of English grammar.

- Proficient in Microsoft 365.

- Familiarity or experience with artificial intelligence and other emerging technology is preferred.

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

$60,000.00---$100,000.00

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. 

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.