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 Senior/Lead Clinical Regulatory Medical Writer responsible for end-to-end support of clinical regulatory medical writing deliverables for Sponsor projects. The Senior/Lead Writer is responsible for ensuring the preparation of high-quality clinical regulatory documents. The Senior/Lead Writer needs to be familiar with the breadth of eCTD documents and regulatory submissions. This is an advanced writing role for an experienced and independent writer looking to join a growing team of medical writing professionals.
When not directly authoring documents, the Senior/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 a 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 clinical medical 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, immunology, and rare disease) is desirable. Academic requirements include a Bachelor's degree in a relevant scientific discipline; an advanced degree (Ph.D., PharmD, M.D., or M.S.) is preferred.
Generous benefits package included (health, dental, and vision insurance, profit share, 401K match)
Salary is $120,000 and up, depending on experience
Full time, remote position
US residents only
Interested? Qualified? Excited? Apply today!
Contact us HERE.
