Job Description
About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We're changing lives for a living. Are you ready to make a difference?
The Position The Senior Medical Writer works closely with cross-functional project teams to manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program.
Relationships The Senior Medical Writer reports to a Director of Medical Writing.
The Senior Medical Writer is expected to develop and maintain a network of internal relationships with global and local cross-functional study teams, including personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management, and Non-clinical Development.
Essential Functions - Authors, edits, and provides QC review of documents to support clinical trials and regulatory submissions, which may include:
- Clinical study protocols and protocol amendments
- Clinical study reports (CSR)
- Investigator brochures (IB)
- Informed consent and assent forms
- Lay summaries of clinical trial results
- Clinical evaluation plans (CEP) and clinical evaluation reports (CER)
- Pediatric investigational plans (PIP)
- Orphan Drug applications
- Breakthrough Therapy Designation requests
- Clinical summary and overview documents in eCTD format for global regulatory submissions
- Shares knowledge and experience to optimize and simplify the way we work
- Reviews proposed study plans and related documents for their ability to deliver the information required by the target audience
- Initiates knowledge sharing and contributes to process improvements within the medical writing area
- Actively participates in relevant meetings, training sessions, and seminars in the department and relevant project(s)
- Can identify and resolve problems related to Medical Writing projects, processes, or tasks, with management support as needed
- Provides support and training to others in the department
- General Tasks:
- Interprets and accurately presents clinical and statistical data in a clear, concise format
- Leads meetings, drives discussions, and ensures decisions are taken concerning project/trial-specific medical writing issues
- Resolves document content issues and questions arising during the writing process
- Handles numerous tasks simultaneously and is able to navigate some degree of uncertainty
- Maintains up-to-date knowledge and understanding of the laws, regulations, industry standards, and company policies/procedures relevant to Medical Writing. Remains current with respect to the literature on Novo Nordisk therapeutic areas and competitor products
Physical Requirements Approximately 10% overnight travel. May include travel outside the US.
Qualifications - Education Level:
- Minimum of BS/BA, preferably in a health-related or scientific discipline
- Experience Level:
- 7+ years of relevant experience
- Minimum of 5 years clinical/regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO environment
- Equivalent experience with advanced degree or in other settings will be considered
- Specific or technical job skills:
- Exceptional written and oral communication skills, with mastery of English grammar and punctuation
- Demonstrated understanding of clinical research principles and the drug/device development process
- Keen attention to detail to ensure the accuracy and consistency of clinical trial documents
- A strong foundation in scientific knowledge enables the Medical Writer to understand and interpret clinical trial data and scientific literature
- Able to collaborate with individuals across different time zones and ensure efficient communication and coordination with team members worldwide. This role requires adaptability and strong organizational skills to effectively manage projects and meets deadlines across various geographical locations
- Therapeutic area experience with cell therapies/advanced therapeutics or metabolic dysfunction-associated steatohepatitis (MASH) desired
- Managerial experience:
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Job Tags
Full time, Local area, Worldwide, Night shift,