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Job Title: Medical Writer

Job Description

This role involves the review and preparation of clinical and regulatory documents to ensure compliance with regulatory requirements. The position is responsible for writing a variety of document types according to standard operating procedures, guidelines, and regulatory requirements.

Responsibilities

+ Review and prepare clinical and regulatory documents for compliance.

+ Write clinical study reports and clinical modules for regulatory submission packages.

+ Ensure all documents meet regulatory requirements and company guidelines.

Essential Skills

+ Bachelor's degree in a scientific discipline.

+ Minimum of 10 years of experience in medical writing.

+ Experience as a lead contributing author for NDA submissions.

+ Understanding of regulatory writing in the rare disease field.

+ Proven ability to author NDA submission documents under accelerated timelines.

Additional Skills & Qualifications

+ Familiarity with publication document guidances such as ICJME, GPP, CONSORT Guidelines.

+ Preferred references include the American Medical Association (AMA).

+ Effective problem-solving and critical thinking skills.

+ Adaptability and flexibility to meet client timelines.

+ Enjoys troubleshooting and providing effective solutions.

Work Environment

This position is remote, operating in the Eastern or Central Time Zone. Collaboration with a European team requires flexibility for morning meetings. The role offers the exciting opportunity to work on NDA submissions within the rare disease space.

Pay and Benefits

The pay range for this position is $100.00 - $100.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 17, 2025.

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.