Lead Clinical Medical Writer

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 Writer is responsible for ensuring the preparation of high-quality clinical regulatory documents. The Lead Writer needs to be familiar with the breath of eCTD documents and regulatory submissions. 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 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.

Qualifications:

The right candidate for this job is an experienced writer with ≥5 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 preferred. 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!