"Alerted.org

Lead Medical Writer

Job Description

We are seeking a highly experienced Senior Medical Writer to join our team and contribute significantly to our growing workload. This role involves writing specific clinical and regulatory documents while managing the process efficiently, ensuring successful cross-functional collaboration.

Responsibilities

+ Create and manage clinical and regulatory documents, including Protocols & Amendments, Clinical Study Reports (CSRs), Investigator Brochures, and Meeting Briefs.

+ Work collaboratively across functions to gather necessary information for document creation.

+ Contribute to both clinical and regulatory writing processes, ensuring accuracy and compliance.

Essential Skills

+ 10+ years of medical writing experience.

+ Experience with clinical and regulatory documents.

+ Experience working with a sponsor, preferably in small pharma.

+ Bachelor's degree in a relevant field.

+ Experience in rare diseases is preferred.

+ Experience with global submissions is advantageous.

Additional Skills & Qualifications

+ Biotech or Pharma experience, especially in small biotech or pharma environments.

+ Project management skills.

Work Environment

This is a 100% remote role, offering a long-term, consistent consulting opportunity. Work closely with the Head of Medical Writing in a fast-paced, collaborative environment. Although work hours vary between 30-40 hours per week, flexibility is required.

Pay and Benefits

The pay range for this position is $90.00 - $115.00/hr.

Workplace Type

This is a fully remote position.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.