Medical Writer Job at Novo Nordisk, Lexington, MA

WHdjamNrdktzc2ZuWWJza1p1S3QyaE5kS1E9PQ==
  • Novo Nordisk
  • Lexington, MA

Job Description

About the Department

Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our greater Boston R&D 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.

 

The Position

The 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.

 

Relationships

The 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

 

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:
    • 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

 

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

Local area, Worldwide, Night shift,

Similar Jobs

Undefeatable Foundation

Fundraising Volunteer Job at Undefeatable Foundation

 ...Do you have experience fundraising for nonprofits Are you not afraid to do some cold calling Do you have connections Do you love technology Then continue reading! What we do: Help youth travel and learn a language! A nonprofit nongovernmental organization changes... 

Florida Legislature

It auditor Job at Florida Legislature

 ...An IT Auditor performs responsible professional work in conducting information technology (IT) audits at State agencies, educational entities, and local governmental units. Applicants with professional experience may be considered for a higher-level position. Individuals... 

Tek Inspirations LLC

Sap Job at Tek Inspirations LLC

 ...experience with S/4 implementations utilizing a Smart Brownfield approach through Selective Data Transition tools/services (SNP, SAP DMLT, CBS, etc.) Must have 4+ years of recent experience working with all core areas of S/4 Finance (GL, Cost Accounting, Profit Center... 

The Borgen Project

Writer/Journalist Internship Job at The Borgen Project

The Borgen Project is an innovative, national campaign that is working to make poverty a focus of U.S. foreign policy. This is a 12-week, part-time, unpaid internship. However, if your availability is limited, you can work ahead and complete the program in fewer weeks. ...

Ray Autogroup

Automotive Finance Manager Job at Ray Autogroup

Ray Auto Group, a leading Northern Illinois Auto Group, is searching for an experienced F&I Manager. Applicant must have a proven track record and references. Possibility to make over 300K! Excellent compensation and benefit package. Please send your resume in confidence...