Principal Medical Writer

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, author, and provide submission-ready documents, including protocols, IBs, DSURs, CSRs, INDs, responses to Health Authorities, and briefing documents.

• Take the lead on cross-departmental document creation in collaboration with Clinical, Nonclinical, Medical, Biostatistics, CMC, and Regulatory teams.

• Act as a representative for medical writing on internal cross-functional study teams and ad hoc working groups.

• Assist in the preparation of abstracts, posters, and presentations for scientific conferences.

• Create and enhance medical writing processes, templates, and standards.

• Execute and oversee effective document workflows and timelines.

• Engage in the assessment and integration of AI-enabled tools to enhance writing quality and efficiency.

• Report directly to the Head of Medical Writing.

• Contribute to Iambic Therapeutics’ mission of developing innovative, patient-centered therapeutics through AI-driven drug discovery and development.

⛳️ Requirements

• A Bachelor’s degree in a life science or health-related field is required.

• An advanced degree (Master’s, PhD, or PharmD) is preferred.

• At least 10 years of relevant experience in medical writing is necessary.

• Proven experience with IND submissions and documentation supporting clinical-stage programs is essential.

• Exceptional scientific writing, communication, and organizational abilities are required.

• Proficient in Microsoft Office suite, particularly MS Word.

• Experience with electronic document and reference management systems is preferred.

• A strong aptitude and willingness to learn and adopt new technologies, including AI-enabled tools.

• Solid knowledge of FDA/EMA regulations and ICH guidelines is needed.

• Must be comfortable working and collaborating in a fast-paced environment.

• Must currently be authorized to work in the United States.

• Must not require visa sponsorship now or in the future.

🏝️ Benefits

• Company-paid healthcare.

• Flexible spending accounts.

• Voluntary life insurance.

• 401(k) matching.

• Uncapped vacation.

• Onsite gym.

• Onsite dining.

• Brand-new state-of-the-art facility in San Diego.

• Convenient access to excellent living and recreational areas.