Director of Clinical Medical Writing

Role

Join our strong and growing team! Acumen Medical Communications, a leader in medical writing services, is looking for a full time remote Director of Clinical Medical Writing. The Director of Clinical Medical Writing is responsible for ensuring the preparation of high-quality clinical regulatory documents and providing strategic direction to the Acumen writing team. The Director needs to be familiar with the breath of eCTD documents and regulatory submissions. This is a management role with oversight of customers, projects, and writing staff. Some direct writing may also be required.

The Director works closely with other Acumen managers and writers to maintain an efficient and informed document development process. As a client-facing manager, the Director will work along side the Sponsor to ensure smooth project conduct and achieve customer success.

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. The Director will collaborate with other functional leads and play an important role in the growth of our staff writers and editors.

• Generous benefits package included (health and dental and vision insurance, profit share, 401K match)

• Salary is $210,000, 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 10 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 a proven ability to lead and develop a team of regulatory writers.

  • Previous experience leading or mentoring medical writers is required.

• 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 writing and leading key components of NDA or BLA submissions.

• 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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