Genmab Senior Medical Writing Manager in Princeton, New Jersey
Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
We are looking for a highly motivated, independent and talented Medical Writing Manager/Senior Manager. In this role, you will be responsible for driving, developing, and writing clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. As Medical Writing Manager/Senior Manager, you will be responsible for 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 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 with a team-player mindset.
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.
Your key responsibilities will be:
Draft and edit documents used to support clinical trial conduct and reporting, including clinical trial protocols, investigator's brochures, and clinical study reports, Health Authority briefing packages/ responses, and clinical CTD submission documents.
Drive cross-functional team participation in the preparation of such documents, including calling/scheduling/facilitating meetings, developing and managing timelines, document review, and decisions.
Provide peer review and editing support for other clinical/regulatory documents, as needed.
Adhere to guidelines, SOPs, and practices and technical and industry standards during all aspects of work.
Support developing and reviewing standard processes and templates.
Work effectively in cross-functional working groups.
Skills and experience
At least 5 years (Manager) or 7 years (Senior Manager) relevant medical or scientific writing experience in the pharmaceutical industry. Oncology experience required.
Familiarity with all phases of drug development processes (discovery to market), clinical trial protocol design, CTA/IND submissions, investigator's brochures, plans required for the conduct of clinical trials, and clinical trial data collection and results reporting.
Experience authoring oncology clinical trial protocols (Phase 1-3) and clinical components in oncology regulatory filings (NDA, BLA, MAA) is required. Additionally, experience preparing investigator's brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses.
Knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
General understanding/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).
Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, EndNote, document management systems.
Ability to interpret and summarize tabular and graphical data presentations.
Moreover, you meet the following personal requirements:
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.
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab's culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
Please note that if you are applying for a position in the Netherlands; Genmab's policy for all permanently budgeted hires in this location is to offer a temporary agreement for one year, followed by a contract for indefinite time regardless of seniority.
Equal Opportunity Employer-minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity