Director of Clinical Medical Writing

Acumen Medical Communications, a leader in medical writing services, is looking for a full time remote Director of Clinical Medical Writing. This critical leadership role provides an opportunity to shape the growth of a key service line within Acumen. Consider joining this premier organization providing best-in-class clinical development support.

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.

The right candidate for this job is an experienced regulatory writer with ≥10 years of direct writing experience within the pharmaceutical or biotechnology industry for Sponsors and/or CROs. Robust experience with leading all aspects of core clinical regulatory documents including clinical study protocols, clinical study reports, investigator’s brochures, type B and type C briefing books, and DSURs is required. Experience leading or heavily contributing to key components of an NDA or BLA submission is also required. The candidate should possess strong leadership and team management skills. Demonstrated experience leading or mentoring medical writers is required. Strong attention to detail and excellent written and verbal communication skills and a proficiency with Microsoft Word and other relevant software tools is mandatory. Knowledge of therapeutic areas relevant to our portfolio (including oncology and immunology) is desirable. Academic requirements include a Bachelor's degree in a relevant scientific discipline; while an advanced degree (Ph.D., PharmD, M.D., or M.S.) is preferred.

• Generous benefits package included (health and dental and vision insurance, profit share, 401K match)
• Salary is dependent on experience
• Full time, remote position US residents only

Interested? Qualified? Excited? Apply today!