The Principal Medical Writer (PMW) is an expert in medical writing and performs work independently with minimal supervision. The PMW will work closely with cross-functional project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The PMW will provide high level strategic input into development plans, study designs, and regulatory submissions.
The PMW reports to a Director of Medical Writing. The PMW is expected to develop and maintain a strong network of internal relationships with global and local cross-functional study teams. The PMW should be seen as a key resource for medical writing expertise and provides active leadership on local and global project teams, as needed. The PMW will provide mentoring and direction to less-experienced medical writers, as needed.
- Authors and reviews documents to support clinical operations and regulatory submissions, including:
- Clinical study protocols and protocol amendments.
- Clinical study reports (CSR).
- Informed consent and assent forms.
- Lay summaries of clinical trial results.
- Clinical evaluation plans (CEP) and Clinical evaluation reports (CER).
- Investigator brochures (IB).
- Responses to requests from regulatory agencies and ethics committees.
- Clinical summary and overview documents in eCTD format for global regulatory submissions, including investigational medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), marketing authorization applications (MAA), and new drug applications (NDA).
- Pediatric investigational plans (PIP).
- Orphan Drug applications.
- Breakthrough Therapy Designation requests.
- Deliverables for meetings with Regulatory Agencies (meeting requests, briefing books, slides. minutes).
- Publication Support:
- Collaborates with local and global publication groups, journals, editors, authors, and others as necessary to ensure the successful completion of publication projects.
- Prepares and reviews manuscripts, meeting abstracts, scientific poster presentations, and other documents necessary for publication support. May be responsible for planning and leading author meetings.
- General Tasks:
- Works independently at a highly proficient level, without appreciable direction.
- Provides leadership in local and global project teams and facilitates collaboration and collective decision making.
- Leads meetings and drives decisions concerning project/trial-specific medical writing issues.
- Independently resolves document content issues and questions arising during the writing process.
- Assesses the quality of documents; provides findings and clear feedback to document authors.
- Provides advanced input into study designs, analysis plans, and regulatory submissions/ applications.
- Analyzes proposed study plans and related documents for their ability to deliver the information required by the target audience.
- Collaborates with others to develop key messages for complex clinical/regulatory documents.
- Interprets and accurately presents clinical and statistical data in a clear, concise format.
- Can identify and resolve moderately complex problems related to Medical Writing projects, processes, or tasks, with management support as needed.
- Provides mentorship, guidance, or training to less-experienced Medical Writers.
- 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.
Approximately 10% overnight travel. May include travel outside the US.
- Education Level:
- Minimum of BS/BA, preferably in a health-related or scientific discipline.
- Experience Level:
- Minimum of 7 years clinical/regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO environment.
- Specific or technical job skills:
- Demonstrated understanding of clinical research, the drug/device development process, and applicable regulatory guidelines.
- Demonstrated understanding of statistical approaches in clinical study design and analysis.
- Exceptional written and oral communication skills, with mastery of English grammar and punctuation.
- Expert-level word processing and formatting skills.
- Managerial experience:
- Experience managing or mentoring other medical writers is a plus.