Acumen Medical Communications (Contract) Nonclinical Lead Medical Writer Remote · Contractor Company website

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Acumen Medical Communications is a world-premier medical writing and regulatory communications firm serving the pharmaceutical, biotech, and healthcare industries. In addition to our core writing, editorial, and publishing services, we provide deep scientific expertise, precision quality control, and advanced technology solutions purpose-built for regulatory and clinical development. To deliver on this commitment, we place a strong emphasis on attracting top talent and compensating them accordingly.

The (Contract) Lead Nonclinical Medical Writer works with Sponsor and Acumen teams to prepare high‑quality documents for regulatory agencies. This individual supports Sponsor drug development by being responsible for the accuracy, compliance, and timely completion of nonclinical documents, ensuring successful regulatory submissions. The Lead Nonclinical Medical Writer will also contribute to the strategic direction of the Acumen writing team and must be familiar with the breadth of nonclinical eCTD documents.

Responsibilities:

• Managing the planning, development, and review of a variety of nonclinical regulatory documents, including Module 4 study reports, Pre-IND briefing documents, Investigator Brochures, INDs, Fast Track applications, NDAs, BLAs, and regulatory responses
• Interface with Sponsor teams to gather all source information and data necessary for document development
• Apply previous experience and working knowledge of key regulatory guidelines, such as ICH, GCP, and FDA guidance, to ensure document compliance
• Collaborate with Acumen teams, including clinical writing, publications, project management, and quality control, to support regulatory submissions
• Manage project timelines and priorities to meet document and submission deadlines
• Provide mentorship, training, and guidance support to internal writing teams
• Contribute to process improvement initiatives within the Nonclinical Medical Writing Department
• Maintain a strong commitment to quality and adherence to Acumen company values

 

General Qualifications:

• A minimum of 3 to 5 years of experience in the field, with a strong track record in nonclinical document writing, including Module 4 study reports, Module 2 eCTD summaries, and pre-IND briefing documents
• An advanced scientific degree, preferably a PhD, in the biological sciences
• Ability to work effectively in a fast-paced and collaborative environment
• Strong leadership and team management skills, including mentoring junior medical writers
• In-depth knowledge of regulatory requirements, guidelines, and standards (e.g., ICH, FDA, EMA)
• Regulatory agency interaction experience is a plus
• Detail-oriented, with excellent written and verbal communication skills