Senior Manager Medical Writer (QC)

Job Title: Senior Manager Medical Writer (QC) PART TIME 30 hours a week

Job Description

The Senior Manager Medical Writer (QC) will lead the preparation of clinical and regulatory documents, including protocols, investigator brochures, safety updates, clinical study reports, and various submission documents. This role requires adherence to global and regional regulatory guidelines and company standards. You will collaborate with functional leads to plan content and create timelines, ensuring organization, clarity, and consistency across all documents.

Responsibilities

• Lead the preparation of clinical and regulatory documents in accordance with applicable guidelines and standards.
• Plan content in partnership with functional leads and create timelines for document development.
• Ensure organization, clarity, scientific standards, formatting, and consistency within and across documents.
• 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 diverse, cross-functional teams, fostering an atmosphere of openness and trust.

Essential Skills

• Expertise in medical writing, oncology, and drug development.
• Ability to apply critical thinking, scientific writing principles, data interpretation, and knowledge of regulatory content life cycle.
• Experience with protocol writing and IND/NDA submissions.
• Bachelor’s degree in life sciences; master’s or doctorate degree preferred.
• Minimum of 8 years of direct medical writing experience, with at least 3 years in oncology drug development.
• Proven ability to produce high-quality writing and prepare complex clinical and regulatory documents.
• Strong project management and team facilitation skills.

Additional Skills & Qualifications

• Ability to influence without authority and foster productive exchange of ideas.
• Experience managing increasingly complex projects.
• Understanding of interdependencies of contributing functions (e.g., clinical pharmacology, biomarkers).
• Adaptability to changing environments and competing priorities.
• Effective communication skills to present ideas and data to Senior stakeholders.
• Familiarity with document preparation tools and automation.
• High-level technical, statistical, and computer skills for interpreting clinical data.

Work Environment

This is a remote position operating on PST hours, with part-time commitment of up to 30 hours a week.

This is a Contract position based out of South San Francisco, CA.

The pay range for this position is $130.00 - $155.00/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 Feb 6, 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.

Salary : $130 - $155