Principal Medical Writer

Role Summary:

As Principal Medical Writer, you will lead or make key contributions to clinical and regulatory documents within our organization. You will be responsible for developing high-quality documents that support our clinical studies, including clinical study protocols, their amendments, clinical study reports (CSRs), investigator’s brochures (IBs), and annual reports and/or development safety update reports (DSURs). As needed, you will support other regulatory documents and submissions, such as briefing documents and responses to regulatory agencies. 
 
You will collaborate with subject matter experts (SMEs) from the preclinical development, clinical development, clinical operations, translational science, drug safety, biometrics, and regulatory affairs teams to meet aggressive timelines. You will project manage high-quality documents from start to finish, develop strong relationships, and act as cross-functional lead.  

Key Responsibilities:

• Lead development of clinical study protocols, amendments, IBs, and other supporting documents
  • Develop timelines for clinical documents in collaboration with our team and our CROs. Ensure that protocols will be authored, reviewed, and finalized in time for regulatory submission(s) and study execution.  
  • Co-author protocols and IBs with cross-functional SMEs. Ensure required elements are clearly described and documents comply with ethical and regulatory standards. Manage review cycles (including collaboration with stakeholders to address comments). Finalize and publish documents.  
  • Review or contribute to supporting study documents, including (but not limited to) informed consent forms, study charters, or pharmacy manuals, if required. 
    
    
• Lead the development of CSRs and data summaries for INDs, CTAs, BLAs, and MAAs 
  • Work closely with the clinical development, translational science, data management, and/or biometrics SMEs to plan for the data that we expect to report in our CSRs. Co-author robust CSR shells in preparation for database lock(s).  
  • Co-author CSRs with accurate and concise interpretations of the results. Manage review cycles. 
  • Prepare written summaries for submission to regulatory agencies. Ensure key messages are clear and consistent across and within documents. 
  • Lead data integrity reviews of CSRs and data summaries, ensuring that the data and interpretations are consistent with TLFs and raw data. 
  • Respond to information requests from regulators in a professional and efficient manner. 
• Author and/or support content for meetings with regulators or key opinion leaders, including briefing packages, scientific abstracts and articles. 
• Identify risks and contribute to risk mitigation or contingency planning for submission activities. 
• Contribute to the maintenance of document templates, job aids, and training materials. Identify opportunities for process improvement. 
• Advocate across cross-functional teams to implement industry best practices such as lean authoring and strategic review. 

Ideal Candidate:

• Bachelor's degree in a scientific discipline, preferably in Pharmacy, Chemistry, Biology, or related field. Advanced degree (MS, PhD, MD, PharmD) is a plus. 
• A minimum of 6+ years of experience in pharmaceutical medical writing and/or related disciplines (note: advanced degree + fewer years of experience will be considered). 
• Proven track record of successfully managing clinical study protocols, their amendments, study reports, investigator’s brochures, and other key clinical and regulatory submission documents. 
• Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements.  
• Knowledge of drug-drug and biologic-biologic combination products as well as the design of clinical studies for such products is a plus. 
• Excellent leadership, collaboration, communication, and interpersonal skills. 
• Strong problem-solving and critical thinking abilities. 
• Ability to meet deadlines and adapt to changing priorities. 
• Proficiency in word processing software and document management systems.

What We Offer:

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $170,000 to $202,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.