Genmab A/S
Associate Director, Medical Writing
Genmab A/S, Princeton, New Jersey, us, 08543
Associate Director, Medical Writing
At Genmab, we’re committed to building extraordinary 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 an individual contributor/technical position, not a 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 of 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. 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 (e.g., assessment and implementation of AI technologies) as Genmab continues to achieve on its 2023 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 (e.g., 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 $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 Us 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.
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At Genmab, we’re committed to building extraordinary 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 an individual contributor/technical position, not a 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 of 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. 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 (e.g., assessment and implementation of AI technologies) as Genmab continues to achieve on its 2023 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 (e.g., 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 $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 Us 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.
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