Nonclinical Lead Medical Writer

Acumen Medical Communications; United States; Remote; USD 120,000 - 140,000; Full time

Job summary

Acumen Medical Communications is seeking a Senior/Lead Nonclinical Writer to join their remote team. This role involves authoring regulatory documents and mentoring junior writers in a supportive environment. The company offers a competitive salary starting at $120,000 along with generous benefits, emphasizing collaboration and knowledge sharing.

Benefits

Health insurance

Dental insurance

Vision insurance

Profit sharing

401K match

Qualifications

• 3 to 5 years of experience in nonclinical document writing.
• Knowledge of regulatory requirements and standards.
• Experience in oncology and immunology is desirable.

Responsibilities

• Author and oversee nonclinical regulatory documents.
• Interact with sponsors and lead junior writers.
• Manage projects with quality control and software development teams.

Skills

Attention to detail

Communication skills

Leadership

Collaboration

Education

PhD in biological sciences

Tools

Microsoft Word

Job description

Join to apply for the Nonclinical Lead Medical Writer role at Acumen Medical Communications.

Get AI-powered advice on this job and more exclusive features.

Acumen was established by industry-experienced medical writers and clinicians with the vision of creating a world-leading medical writing company that places writers at the forefront. Our primary objective is to cultivate a supportive and collaborative environment where writers can thrive and deliver exceptional work. With a track record of serving over 100 sponsors in the pharmaceutical and biotechnology industry, our medical writing teams make significant contributions to drug regulatory submissions (INDs, CTAs, NDAs, and BLAs) and publications across diverse therapeutic areas.

We are currently seeking a highly skilled Senior/Lead Nonclinical Writer to join our growing team as a remote, permanent employee. In this role, you will directly interact with sponsors to author and oversee a wide range of nonclinical regulatory documents. Lead Nonclinical Writers may work as individual contributors or team leaders, supported by our quality control, project management, and software development teams. The role may expand to include management and training of junior nonclinical writers.

At Acumen, we support and train well-rounded clinical developers. Our culture emphasizes sharing knowledge and providing cross-functional training opportunities. To attract top talent, we offer a competitive compensation package:

• Generous benefits including health, dental, and vision insurance, profit sharing, and 401K match
• Salary starting at $120,000, depending on experience
• US residents only

Qualifications:

• 3 to 5 years of experience in nonclinical document writing, including Module 2 eCTD summaries, pre-IND briefing documents, and nonclinical study reports
• Advanced degree in biological sciences, preferably a PhD
• Ability to work collaboratively in a fast-paced environment
• Strong attention to detail and excellent communication skills
• Knowledge of regulatory requirements and standards
• Proficiency in Microsoft Word and relevant software
• Leadership and mentoring skills for junior writers
• Knowledge of therapeutic areas like oncology and immunology is desirable

If interested, please send your resume and a brief cover letter. We look forward to hearing from you!