Medical Writer - Lexington, United States - Novo Nordisk

Novo Nordisk

Verified Company

Lexington, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

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)
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/trialspecific 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 uptodate 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 healthrelated 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 dysfunctionassociated 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 empl