Role Summary

As Director, Medical and Regulatory Writing, you will make key contributions to clinical and regulatory documents within our organization. You will be responsible for drafting, revising, and finalizing the 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). 

You will work closely with subject matter experts (SMEs) from the preclinical development, clinical development, clinical operations, translational science, drug safety, biometrics, and regulatory affairs teams. Initially, you will make substantive individual contributions to key documents, but as needs grow, you may oversee team members and/or external vendors and consultants to assist you in your projects. 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, and supporting documents
  • Develop project plan(s) for protocols 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 (with SMEs), ensuring study design(s) are clearly described and comply with ethical and regulatory standards. Draft region-specific language that addresses global requirements and requests. Organize reviews. Collaborate with stakeholders to address comments. Finalize and publish documents. 
  • Co-author and/or review supporting study documents, including (but not limited to) investigator’s brochures, informed consent forms, and pharmacy manuals.
• 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 team(s) to understand the data that we expect to report in our CSRs. Co-author CSR shells in preparation for database lock(s). 
  • Collaborate with SMEs and CROs to plan for and generate the study results that are needed to complete CSRs.
  • Review study results when available. Co-author (with SMEs) summaries and interpretations of the results; Create tables and figures; Incorporate summaries and information into CSR shells.
  • Lead data integrity reviews of CSRs, ensuring that the data and interpretations are consistent with TLFs and raw data.
  • Prepare written summaries of the data for submission to regulatory agencies in our IND(s), CTA(s), and marketing applications (BLAs and MAAs); Respond to information requests from regulators in a professional and efficient manner.
• Create document templates for our protocols and CSRs and help us adhere to them:
  • Create and update protocol and report template(s) for use in future studies.
  • Collaborate with the team to create style guides, ensuring that our documents have a professional and consistent appearance and conform to regulatory requirements (e.g., International Conference on Harmonization (ICH) and other relevant guidelines).
  • Format and publish our clinical/regulatory documents, and/or collaborate with the regulatory operations team to ensure that documents are formatted/published.
• Author and/or support content for meetings with regulators and key opinion leaders, including briefing packages, scientific abstracts and articles, and other materials.
• Take a leadership role within the regulatory and medical writing team(s)
  • Ensure that the company has the necessary processes, personnel, and consultants to draft our clinical/regulatory documents. 
  • Suggest improvements to our processes and templates for better quality, efficiency, and productivity.
  • Oversee contractors and guide team members. In the future, as needed, hire, train, and mentor junior employees.
  • Contribute to development and management of the regulatory affairs/medical writing budget, ensuring cost-effective use of resources.

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 8 years of experience in pharmaceutical medical writing and/or related disciplines (note: advanced degree fewer years of experience will be considered, and applicants with less experience may be considered for the associate director level).
• Proven track record of successfully managing clinical study protocols, their amendments, study reports, investigator’s brochures, and other key 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, 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.

What We Offer

• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture of our young company, wear multiple hats, 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 year.
• Commitment to growing you professionally and providing access to resources to further your development.
• 100% remote team with frequent in-person meetings to build relationships and problem solve.

The expected salary range offer for this role is $212,000 to $233,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.