Part Time Contract (15-20 hours per week)

Contract should go through the end of 2026

Job Title: Medical Writer - Regulatory Strategy

Job Description

We are seeking an expert-level Medical Writer to work approximately 15-20 hours per week on a series of ongoing projects through 2026. This remote position involves minimal oversight and requires a self-sufficient, proactive individual with strong communication skills. Collaboration with Subject Matter Experts (SMEs) is essential for compiling comprehensive reports and submissions.

Responsibilities

Orient and familiarize yourself with the product and regulatory status, including reviewing IND submissions and amendments.Write a synoptic Clinical Study Report (CSR) focusing on safety for a Phase 1b breast cancer study.Assemble a full CSR for a lung cancer Phase 1b study, focusing on safety and efficacy results.Review and contribute to the Fast Track application from a medical writing perspective.Prepare the Annual IND Update in DSUR format, including an IB update.Assist in writing a Type C meeting request briefing deck.Contribute to the writing of an Orphan Drug Application submission if feasibility is positive.Consider amendments to the Phase 2 lung cancer protocol to increase sample size.Draft a basket study protocol for up to three cancer types.Assist with preparations for the End of Phase 2 meeting with the FDA.

Essential Skills

Expertise in medical writing and regulatory strategy.Experience with FDA submissions and clinical research.Proficiency in writing Clinical Study Reports (CSRs) and synopses.Strong understanding of IND, FDA submissions, and study reports.

Additional Skills & Qualifications

Experience in oncology or medical imaging is advantageous.Familiarity with electronic databases and TLFs is beneficial.

Work Environment

This role is entirely remote, offering flexibility to attend weekly Wednesday morning meetings if available. Fully Remote position.

Job Type & Location

This is a Contract position based out of Chesterfield, MO.

Pay and Benefits

The pay range for this position is $95.00 - $115.00/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 Feb 13, 2026.

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 actalentaccommodation@actalentservices.com for other accommodation options.