REMOTE Sr Manager Medical Writing- Sponsor

Overview

Job Title:

Senior Manager, Medical Writing

Company:
Small Sponsor

Duration: 18 month contract

REMOTE:
Must be willing to support west coast business hours!

Lead the preparation of clinical and regulatory documents, including but not limited to protocols, investigator brochures, safety updates, clinical study reports, and various submission documents. Ensure adherence to global and regional regulatory guidelines as well as company standards and SOPs. Collaborate with functional leads to plan content and timelines for document development.

• Organize and ensure clarity, scientific standards, formatting, and consistency of content within and across all documents for a program or within a clinical dossier.

• Lead document adjudication meetings and resolve issues with cross-functional contributors.

• Manage the review and approval process, liaising with development partners.

• Work independently and effectively with cross-functional, geographically and culturally diverse teams.

• Establish strong collaborative relationships by creating an atmosphere of openness and trust.

• Minimum of 8 years of direct medical writing experience in the biopharmaceutical industry or related CROs.

• At least 3 years of experience in drug development in oncology.

• Demonstrated ability to produce clear, high-quality writing in English.

• Experience in preparation of a broad range of complex clinical and regulatory documents and global submissions.

• Strong project management and team facilitation skills to lead complex projects in a fast-paced matrix environment.

• Bachelor’s degree in life sciences; master's or doctorate degree in life sciences preferred.

• Ability to influence without authority and foster the exchange of ideas amongst colleagues.

• Experience managing projects of increasing scope and complexity.

• Understanding of interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcomes).

• Ability and willingness to adjust behaviors and priorities based on a changing environment.

• Highly effective communication skills and ability to present ideas and data clearly to a group.

• Familiarity with tools and approaches to expedite document preparation, such as review tools and automation.

• High-level technical, statistical, and computer skills, with the ability to interpret complex clinical data.

This is a remote position operating on PST hours.

This is a Contract position based out of Chicago, IL.

The pay range for this position is $85.00 - $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)

This is a fully remote position.

This position is anticipated to close on Jan 28, 2026.

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 actalentaccom (%20actalentaccom) for other accommodation options.