Description
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.
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.