Associate Director, Medical Writing

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:

• Apply expert medical writing proficiency to lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages.
• Serve as a document planning and writing expert; responsible for guiding a medical writing and project team during the planning and authoring stages across all document types and regulatory submissions, including facilitating document contributor/review meetings, developing and managing timelines, coordinating document review, and driving decision-making.
• Initiate and drive strategic medical writing initiatives and processes with high technical acumen to ensure execution on company priorities.
• Contribute to/lead Medical Writing digitalization efforts (eg, assessment and implementation of AI technologies) as Genmab continues to achieve on its Vision and advance its technological and digital capabilities.
• Lead, and actively contribute to, the development, review, implementation, and improvement of departmental processes, policies, standard operating procedures, training, and work guidance as applicable. Own relevant medical writing processes; lead medical writing SOP creation/update initiatives.
• Closely coordinate with the Technical Document Manager and Document Quality Control groups to ensure adequate planning and end-to-end support for high-quality deliverables.
• May be responsible for managing the oversight of medical writing vendors/CROs, ensuring high performance standards are met.
• Proactively lead and/or engage in department activities and serve as a mentor for junior writers.
• Actively provide input to the overall strategy, unified objectives, and areas for development of the Medical Writing department.

Requirements - what you must have

• BA/BS degree in life sciences and at least 10 years’ medical or scientific writing experience, in the pharmaceutical industry. Oncology and immunology experience highly preferred.
• Extensive experience writing protocols, investigator’s brochures, clinical study reports, Health Authority briefing packages, Health Authority responses, and Pediatric Investigational Plans (PIPs). Experience authoring clinical components in regulatory filings (NDA, BLA, MAA).
• Expert understanding and knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (eg, protocols, investigator brochures, and clinical study reports), CTA/IND/HA regulatory submissions, plans required for the conduct of clinical studies, and clinical study data collection and results reporting.
• Expert knowledge of document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• Ability to interpret and summarize complex tabular and graphical data presentations.
• Proficiency in the use and understanding of computer software (e.g., word processing, graphics, reference manager, EndNote, document management systems).

About You - additional qualities you bring to the table

• You are self-driven and thrive working in a collaborative, team environment.
• You are capable of working on multiple tasks and shifting priorities, and leading cross-functional teams under strict timelines.
• You are motivated and detail-oriented.
• You have the ability to work across all trial phases and prioritize your own tasks.
• You are a dedicated team player and a great communicator with excellent oral and written communication skills.
• You are proactive and open-minded.
• You have a quality mindset and thrive in a fast-paced and changing environment.
• You are result- and goal-oriented and committed to contributing to the overall success of Genmab.

Additional Job Description

• Independently prepare (or oversee the work of others), edit, and finalize complex, strategic clinical and regulatory documents, including clinical trial protocols/amendments, investigator’s brochures, clinical study reports, PIPs, Health authority briefing packages, Health Authority responses, and clinical CTD submission documents
• As required, support in development and implementation of Medical Writing strategy in line with organizational strategy
• Serve as compound lead writer and medical writing representative on cross-functional study teams and provide guidance on document strategy and content, timelines, and resource needs to  ensure timely completion of tasks with  desired quality
• Drive or oversee smooth and effective document management from template to a final approved version for a project or trial or strategic compound document
• Lead a submission team and ensure quality of documents or sections of documents prepared by self/other writers
• Collaborate with CROs/vendors and internal project teams/departments to assist with project planning and resourcing planning
• Lead development and review of standard processes and templates for continuous process improvement and maintaining high quality and standards, and participate in or drive inter-and intra-departmental knowledge sharing sessions

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

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.