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

Apply for (Contract) Clinical Medical Writer

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.

Acumen seeks an experienced Clinical Medical Writer as a contract role to develop high-quality regulatory documents for submission to Sponsors and regulatory agencies. The Medical Writer works independently or within a team to develop the documents and ensure the accuracy, completeness, and compliance of these documents. The Clinical Medical Writer applies expert knowledge of regulatory requirements and clinical development processes to produce submission-ready documentation that supports the conduct, analysis, and reporting of clinical studies. This role requires a strong understanding of clinical research principles, regulatory guidelines, and data interpretation to ensure clarity and accuracy throughout document development. The role operates within Acumen’s established framework for quality, consistency, and compliance, contributing to the company’s broader goal of delivering world-class medical writing that reflects scientific rigor and operational excellence.

Core responsibilities:

• Lead the planning, development, and review of a variety of regulatory documents, including but not limited to protocols, amendments, Investigator Brochures, DSURs, clinical study reports (CSRs) and select submission documents.
• Collaborate with cross-functional Sponsor teams, including clinical operations, medical, clinical development, regulatory affairs, and quality assurance, to gather and analyze data and information for regulatory documents.
• Collaborate with Acumen teams to support regulatory documents and submissions.
• Interface with client/Sponsor team to manage all assigned regulatory document(s) through all stages of development.
• Ensure that all clinical regulatory documents are prepared in compliance with regulatory guidelines, standards, and company SOPs.
• Review and edit regulatory documents for clarity, accuracy, and scientific rigor.
• Manage project timelines and priorities to meet document and submission deadlines.
• Apply working knowledge of key regulatory guidelines, such as ICH, GCP, and FDA guidance, to document development.
• Stay updated on evolving regulatory requirements and guidelines and communicate relevant information to the team.
• Represent the clinical medical writing department in interactions with clients.
• Contribute to process improvement initiatives within the clinical medical writing department.
• Maintain a strong commitment to quality and adherence to company values.

Qualifications:

• Bachelor’s degree in relevant scientific or medical discipline required; (PhD, MD, or MS) preferred.
• Minimum of 5 years of clinical regulatory writing experience within the pharmaceutical, biotechnology, or CRO environment.
• Demonstrated expertise in authoring clinical regulatory documents, including protocols, CSRs, IBs, DSURs, briefing books, and eCTD submission components.
• Strong working knowledge of applicable regulatory requirements and associated document structures.
• Excellent written and verbal communication skills with attention to scientific accuracy and consistency.
• Proficiency in Microsoft Word and other document management systems.
• Ability to manage multiple complex projects within established timelines.
• Experience with NDA or BLA submissions preferred.
• Familiarity with therapeutic areas relevant to Acumen’s portfolio, including oncology and immunology, preferred.
• Strong attention to detail, with the ability to manage multiple projects and maintain accuracy under tight deadlines.
• Excellent written and verbal communication skills and the ability to collaborate effectively within cross-functional teams.