1 Medical Writer Job in Lexington, MA
Novo Nordisk is Hiring a Medical Writer Near Lexington, MA
The PositionThe 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. The Medical Writer performs work independently under the supervision of more experienced personnel.
RelationshipsThe Medical Writer (MW) reports to an Associate Director of Medical Writing.
The MW 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
- Shares better practices to optimize and simplify the way we work
- 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)
- Leads meetings and drives decisions concerning project/trial-specific medical writing issues
- Resolves document content issues and questions arising during the writing process
- General Tasks:
- Interprets and accurately presents clinical and statistical data in a clear, concise format
- Can identify and resolve problems related to Medical Writing projects, processes, or tasks, with management support as needed
- 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
Qualifications
- Education Level:
- Minimum of BS/BA, preferably in a health-related or scientific discipline
- Experience Level:
- 5 years of relevant experience. Minimum of 3 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 meet deadlines across various geographical locations
- Therapeutic area experience with cardiovascular or metabolic disorders, including metabolic dysfunction-associated steatohepatitis (MASH) desired
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 Summary
Full Time
Pharmaceutical
$82k-101k (estimate)
05/18/2024
07/12/2024
novonordisk-us.com
PLAINSBORO, NJ
200 - 500
1923
Private
DOUG LANGA
$5B - $10B
Pharmaceutical
Related Companies
The job skills required for Medical Writer include Medical Writing, Clinical Research, Attention to Detail, Clinical Trial, CSR, Regulatory Affairs, etc. Having related job skills and expertise will give you an advantage when applying to be a Medical Writer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Medical Writer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Medical Writer positions, which can be used as a reference in future career path planning. As a Medical Writer, it can be promoted into senior positions as a Medical Writer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Medical Writer. You can explore the career advancement for a Medical Writer below and select your interested title to get hiring information.
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