As Associate Director, Medical Writer, you will lead or make key contributions to clinical and regulatory documents within our organization. You will be responsible for medical writing strategy and timely deliverables for one or more projects, submissions or programs. You may be responsible for oversight of medical writing consultants or other writers on complex, high-stakes documents or submissions.

You will collaborate with cross-functional subject matter experts (SMEs) to meet aggressive timelines. You will project manage high-quality documents and/or submissions from start to finish, develop strong relationships, and be an advocate for best practices in Medical Writing.

Key Responsibilities: 

• Serve as the Medical Writing contact for projects, submissions, or programs. Collaborate with manager and with other functions on planning and appropriate resourcing.
• Provide strategic input to program team(s), ensuring business goals and regulatory needs are met.
• Lead the medical writing planning and deliverables for INDs, CTAs, BLAs, or MAAs.
• Develop timelines in collaboration with our team. Plan for any required data with SMEs.
• Author key clinical, nonclinical and regulatory documents, including but not limited to clinical study protocols, amendments, IBs, CSRs, data summaries, CTD summaries, briefing books and regulatory responses.
  • Interpret and explain data in a manner consistent with the audience. Ensure required elements are clearly described and documents comply with ethical and regulatory standards.
  • Manage review cycles; collaborate with cross-functional stakeholders to address comments.
  • Coordinate QC, finalization and publication of documents.
  • Review or contribute to supporting study documents, including but not limited to informed consent forms, study charters, or pharmacy manuals, if required.
  • Ensure key messages are clear and consistent across and within documents.
• Provide status updates to keep teams, the department, and leadership informed.
• Identify risks and contribute to risk mitigation or contingency planning for submission activities.
• Proactively contribute to process improvements and standards across the team. Develop or maintain document templates, job aids, tools, and training materials.
• 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 8+ years of experience in regulatory medical writing is required.
• Proven track record of successfully leading complex or high-stakes submissions.
• Ability to manage multiple projects and timelines simultaneously.
• Proven track record of authoring high-quality clinical and regulatory documents, including for complex document types.
• Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements.
• Excellent leadership, collaboration, communication, and interpersonal skills (taking initiative, problem solving, conflict resolution, change management, strategic thinking). 
• Ability to meet deadlines and adapt to changing priorities.
• Expert in word processing software (e.g., Office) and document management systems (e.g., Veeva).

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 $199,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.