Lead Clinical Medical Writer
Overview
Join our strong and growing team! Acumen Medical Communications, a leader in medical writing services, is looking for a full time remote Lead Clinical Medical Writer. The Lead Clinical Medical Writer is responsible for ensuring the preparation of high-quality clinical regulatory documents. The Lead Clinical Medical Writer has a critical role in managing and developing the documents and in ensuring the accuracy, completeness, and compliance of these documents. The Lead Clinical Medical Writer needs to be familiar with the breath of eCTD documents and regulatory submissions. This individual will work closely with the Sponsor team to ensure smooth project conduct and achieve customer success. This is a principal-level writing role for an experienced and independent writer looking to join a growing team of medical writing professionals.
When not directly authoring documents, the Lead Clinical Medical Writer works closely with other Acumen writers to maintain an efficient and informed document development process and contributes to providing strategic direction to the Acumen writing team.
Acumen is committed to employing and developing well-rounded clinical developers. Ours is culture of sharing knowledge and expertise and provides opportunities for cross-functional training within the medical writing landscape.
Generous benefits package included (health and dental and vision insurance, profit share, 401K match)
Salary is $160,000, depending on experience
Full time, remote position
US residents only
Qualifications
Bachelor's degree in a relevant scientific discipline; advanced degree (Ph.D., M.D., or M.S.) preferred.
Minimum of 5 years of experience in clinical regulatory writing within the pharmaceutical or biotechnology industry for Sponsors and/or CROs.
Strong leadership and team management skills, with ability to assist in the professional development of regulatory writers.
Previous experience leading or mentoring medical writers is preferred
Experience leading all aspects of the following documents:
Clinical study protocols, clinical study reports, investigator’s brochures, type B and type C briefing books, DSURs, and other regulatory correspondences
Experience leading or heavily contributing to key components (eCTD Modules 2 and 5) of an NDA or BLA submission required
In-depth knowledge of regulatory requirements, guidelines, and standards (e.g., ICH, FDA, EMA).
Strong attention to detail and excellent written and verbal communication skills.
Proficiency in Microsoft Word and other relevant software tools.
Detail-oriented, with a strong commitment to quality and accuracy.
Ability to work effectively in a fast-paced and collaborative environment.
Strong project management skills and the ability to manage multiple projects simultaneously.
Regulatory agency interaction experience is a plus.
Knowledge of therapeutic areas relevant to our portfolio (including oncology and immunology) is desirable.
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