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.
We are looking for a highly motivated and collaborative Associate Director, Medical Writing. This is and individual contributor/technical position, not people-management position. As Associate Director, Medical Writing, you will serve as an expert Medical Writer who is responsible for planning, developing, and writing clinical documents to support medical and regulatory activities across the Genmab portfolio by ensuring that scientifically robust messages and arguments are developed and conveyed consistently across documents. Ideally, you will have an academic degree in life sciences with a broad background that has given you a solid knowledge on clinical drug development and regulatory requirements.
The work done by the Associate Director, Medical Writing is complex and strategic and requires advanced stakeholder management acumen for effective collaboration with internal Genmab-and external collaborative partner company-functions that include, but are not limited to, medical, statistics, programming, trial management, data management, regulatory, nonclinical, CMC, and project management. The successful candidate will have strong analytical skills, high quality standards, and is committed to meet deadlines. In addition, it is essential the candidate is well-organized, proactive, and flexible, and has the ability to work on multiple tasks. simultaneously.
The Associate Director, Medical Writing may be tasked with the development of the following documents, including, but not limited to: clinical trial outlines, clinical trial protocols/amendments, investigators brochures, PIPs, DSURs, CSRs, Health Authority briefing books, clinical submission documents, and other clinical documentation to support the conduct of the clinical trials and regulatory submissions/filings. The Associate Director, Medical Writing may also serve as a document or process subject matter expert, leading cross-functional and cross-department process improvement initiatives.
We offer a position where you will be involved in strategic project, as well as trial-related activities, and will have ample opportunities, responsibilities, and influence on defining your own work. You will also be involved in developing processes and tools to support further development of the department.
Key Responsibilities include:
Requirements - what you must have
About You - additional qualities you bring to the table
Additional Job Description
For US based candidates, the proposed salary band for this position is as follows:
$142,500.00---$237,500.00The 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
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
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.
Northern Montana Health Care is seeking a dedicated and skilled Interventional Radiologist to join our team. This is an exceptional opportunity to make a significant impact in the community while enjoying the pace and quality of life in a rural setting. Job Responsibilities...
...Acutronic Group employs approximately 300 employees across sites in Austin, Texas; Baltimore, Maryland; Pittsburgh, Pennsylvania; Switzerland; Germany; France; and India. Acutronic USA Inc. 700 Waterfront Dr, Pittsburgh, PA 15222 acutronic.com (***) ***-****...
The 150,000-member American Society of Civil Engineers (ASCE) seeks an experienced Grant Specialist/Writer to support the organization's strategic goals and advancing our mission by securing vital funding through the development of impactful grant proposals encompassing...
...improvements and policy development initiatives that impact the function. Qualifications: Bachelor's degree in Finance, Accounting, Economics or related field. MBA or other relevant Master's degree is preferred. A minimum of 5 years of experience in financial planning...
...Job Description At Ouster, we build sensors and tools for engineers, roboticists, and researchers, so they can make the world safer... ...need your help! You will be responsible for building the embedded software that powers our lidar firmware system. Expertise in Linux, C...