Expert Medical Writer Lead
4 hours ago
At Genmab, we're committed to building extraordinary futures together, by developing innovative therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our collaborative environment is designed to foster a culture of innovation, where our people and business thrive together. We're looking for a highly motivated and collaborative Associate Director, Medical Writing to join our team.
This is an individual contributor/technical position, not a people-management role. As an 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. You will ensure 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.
Key Responsibilities- 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.
- 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 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.
- 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.
- 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.
- 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).
At Genmab, we're committed to building extraordinary futures together. We believe that being proud of who we are, determined to be our best, and authentic is essential to fulfilling our purpose. If you're passionate about our mission to transform the lives of patients through innovative cancer treatment and you bring rigor and excellence to all that you do, we'd love to hear from you.
-
Medical Writer
1 month ago
Copenhagen, Copenhagen, Denmark Globant Full timeMedical Writer Job DescriptionGlobant is seeking a skilled Medical Writer to join its team in Copenhagen. As a Medical Writer, you will be responsible for creating scientifically accurate and engaging written content for various healthcare professionals and the general public.Key Responsibilities:Develop compelling headlines, marketing copy, email and...
-
Senior Medical Writer, Clinical Trials
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled and experienced Associate Director, Medical Writing to join our team. As a key member of our Medical Writing department, you will be responsible for planning, developing, and writing complex, strategic clinical and regulatory documents to support medical and regulatory activities across the Genmab...
-
Associate Director, Medical Writing Expert
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled Associate Director, Medical Writing to join our team at Genmab. As a key member of our Medical Writing department, you will be responsible for planning, developing, and writing complex clinical documents to support medical and regulatory activities across our portfolio.Key ResponsibilitiesLead the planning and...
-
Associate Director, Medical Writing Expert
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled Associate Director, Medical Writing to join our team at Genmab. As a key member of our Medical Writing department, you will be responsible for planning, developing, and writing complex clinical documents to support medical and regulatory activities across our portfolio.Key ResponsibilitiesLead the planning and...
-
Medical Writing Director
2 months ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled and experienced Associate Director, Medical Writing to join our team at Genmab. As a key member of our Medical Writing department, you will play a critical role in planning, developing, and writing clinical documents to support medical and regulatory activities across our portfolio.Key ResponsibilitiesLead the...
-
Senior Medical Writing Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we are dedicated to crafting extraordinary futures together by developing innovative antibody products and groundbreaking therapies that significantly impact the lives of patients and the landscape of cancer treatment and serious diseases. Our team embodies values of care, transparency, and a focus on impact, while our business is rooted in...
-
Experienced Danish Translators and Writers
2 weeks ago
Copenhagen, Copenhagen, Denmark Language Bear Full timeLanguage Bear is a leading content creation company that connects clients with talented writers and translators from around the world. Our team of experts is fluent in 60+ languages and has extensive experience in various industries, including Travel & Leisure, Sports, Cosmetics, Fashion, Gambling & Casino, Auto, and Retail.We are currently seeking...
-
Senior Medical Writing Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout GenmabAt Genmab, we are dedicated to crafting extraordinary futures through the development of innovative antibody therapies that significantly impact patient lives and advance cancer treatment and other serious diseases. Our culture is built on the principles of care, transparency, and a commitment to making a difference, driven by a foundation of...
-
Medical Strategy Lead
4 weeks ago
Copenhagen, Copenhagen, Denmark IQVIA Full timeMedical Strategy Lead - Cardiovascular Portfolio GrowthThe IQVIA Cardiovascular Center of Excellence is seeking a Medical Strategy Lead to drive growth of our Cardiovascular portfolio through scientific and clinical expertise. As a subject matter expert, you will be responsible for harnessing IQVIA's vast data and clinical trial resources to develop...
-
Medical Strategy Lead
4 weeks ago
Copenhagen, Copenhagen, Denmark IQVIA Full timeJob Title: Medical Strategy LeadThe IQVIA Cardiovascular Center of Excellence is seeking a Medical Strategy Lead to drive growth of our Cardiovascular portfolio through scientific and clinical expertise. As a subject matter expert, you will be responsible for harnessing IQVIA's vast data and clinical trial resources to develop innovative, data-driven, and...
-
Experienced Danish Translators and Writers
4 weeks ago
Copenhagen, Copenhagen, Denmark Language Bear Full timeJoin Our Team of Expert Danish Translators and WritersLanguage Bear is a leading international content creation company that values expertise and quality. Our team of 1000+ native speakers, working remotely and fluent in 60+ languages, is dedicated to delivering engaging texts that meet the needs of our clients.About the RoleWe are seeking experienced Danish...
-
Technical Writer
1 month ago
Copenhagen, Copenhagen, Denmark Tactile Games Aps Full timeAbout Tactile Games ApsTactile Games Aps is a leading gaming company based in Copenhagen, Denmark. With a diverse team of over 300 talented individuals from 40 nationalities, we pride ourselves on fostering a lean organisational culture that encourages growth, creativity, and collaboration.Job Title: Technical WriterWe are seeking a skilled Technical Writer...
-
Copenhagen, Copenhagen, Denmark WSAudiology Full timeWS Audiology is at the forefront of the medical device industry, navigating a rapidly evolving regulatory landscape.As a pivotal role in our company, we're seeking a Global Senior Regulatory Affairs Specialist to join our team.In this HQ-based position, you will be integral to ensuring that our products meet the highest standards of compliance.Your mission...
-
Associate Director, Medical Writing Lead
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly motivated and collaborative Associate Director, Medical Writing to join our team at Genmab. As a key member of our Medical Writing department, you will play a critical role in planning, developing, and writing clinical documents to support medical and regulatory activities across our portfolio.Key ResponsibilitiesLead...
-
Copenhagen, Copenhagen, Denmark Internetwork Expert Full timeTransform Lives with Innovative Healthcare SolutionsWe are seeking an experienced Associate Director Medical Devices Lifecycle Management to join our Regulatory team at Norgine. As a key member of our team, you will be responsible for the strategic lifecycle management of our Medical Devices post CE approval and the operational execution management with our...
-
Experienced Danish Translators and Writers
1 week ago
Copenhagen, Copenhagen, Denmark Language Bear Full timeLanguage Bear is a global content creation company with a team of over 1000 native speakers, working remotely and fluent in 60+ languages. Our expert writers craft engaging texts that are SEO-friendly and tailored to client needs. We have extensive experience in various topics and have successfully completed projects for industries such as Travel & Leisure,...
-
Medical Advisor
3 weeks ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeAbout the RoleRadiometer Danmark / Danaher is seeking a highly skilled Medical Advisor to join our Clinical & Medical Affairs (C&MA) department. As a Medical Advisor, you will play a critical role in driving key internal and external medical and scientific activities to support our current portfolio and shape future development in acute care diagnostics.Key...
-
Medical Advisor
1 month ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeAbout the RoleRadiometer Danmark, a part of Danaher, is seeking a highly skilled Medical Advisor to drive key internal and external medical and scientific activities. This role will support our current portfolio and shape future development in acute care diagnostics.Key ResponsibilitiesDrive medical input to commercial activities, identifying and networking...
-
Global Medical Affairs Strategy Lead
4 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the Role:The Global Medical Affairs Director will play a pivotal role in providing medical support to the development and execution of the Global Medical Affairs strategic and tactical plans. Key responsibilities include advising on the development of medical education and publication/communication tactics, supporting data generation and life cycle...
-
Medical Strategy Lead
1 month ago
Copenhagen, Copenhagen, Denmark IQVIA Full timeMedical Strategy LeadThe IQVIA Cardiovascular Center of Excellence is expanding its team of clinical innovators. We are seeking a Board-Certified physician with expertise in Cardiology to join our team as a Medical Strategy Lead. This role will drive growth of our Cardiovascular portfolio through scientific and clinical expertise.Key Responsibilities:Develop...
