Senior/Lead Medical Writer - Contract

Role

Acumen Medical Communications, a leader in medical writing services, is looking for remote Senior/Lead Medical Writers. The Senior/Lead Writer is responsible for ensuring the preparation of high-quality regulatory documents. This contract work is on a steady project-by-project basis to support Acumen’s clients in writing and submitting various regulatory documents. Workload is be flexible with up to 25-30 hours a week.

The Senior/Lead Writer needs to be familiar with the breath of eCTD documents and regulatory submissions. This is a writing role for an experienced and independent writer looking to join a growing team of medical writing professionals. This individual will work closely with the Sponsor team 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.

• Extremely competitive hourly compensation.

• Part- to full-time, remote position.

• US residents only.

Core responsibilities

Qualified candidates will have a minimum of 5 years of experience in regulatory writing within the pharmaceutical or biotechnology industry for Sponsors and/or CROs and experience leading either:

Clinical documents: clinical study protocols, clinical study reports, investigator’s brochures, type B and type C briefing books, DSURs, patient safety narratives, NDA/BLA-enabling submission documents.

and/or

Nonclinical documents: Module 4 reports, IND-enabling documents (Module 2.4, Module 2.6 series), briefing books

and/or

Publications: abstracts, posters, manuscripts, conference presentations, publication planning

The Senior/Lead Writer will leverage past regulatory writing experience to lead project teams and manage project timelines and priorities to meet document and submission deadlines. They will collaborate with Acumen teams, including clinical writing, nonclinical writing, publications, project management, and quality control, to support regulatory documents and submissions. The Senior/Lead Writer must provide outstanding customer service to our clients by maintaining a strong commitment to quality and adherence to company values.

Strong attention to detail and excellent written and verbal communication skills are essential as is a strong proficiency in Microsoft Word and other relevant software tools. Experience in oncology, immunology, or rare disease therapeutic areas a plus.

Interested? Contact us HERE