CMC Technical Writer, MSAT

Location: Conshohocken

Job Description

CMC Technical Writer - MSAT (Contract)
? US Remote or Hybrid
? 3-6 Month Contract

About the Role
We are seeking a highly experienced CMC Technical Writer to serve as the primary author for global regulatory submissions supporting commercial pharmaceutical products. This is a high?impact, senior individual contributor role with full ownership of complex CMC content across global markets.

The ideal candidate brings deep expertise in CMC documentation, strong scientific and manufacturing understanding, and proven success writing for FDA, EMA, and other major health authorities.

This role offers full autonomy, cross?functional visibility, and the opportunity to influence regulatory success across a global supply network.
Why This Role Is a Great Opportunity

• Act as the primary CMC author for global submissions on commercial and late?stage assets
• Highly autonomous role with no people?management responsibilities
• Significant impact on regulatory strategy, submission quality, and inspection readiness
• Broad cross?functional exposure (MSAT, Regulatory, Quality, CMOs)
• Remote?friendly position supporting global product lifecycle activities

Key ResponsibilitiesCMC Technical Writing & Documentation

• Independently author and revise complex CMC sections for global regulatory submissions, including original applications, supplements, variations, and technical responses.
• Translate MSAT, manufacturing, and CMO data into clear, accurate, regulator?ready content.
• Ensure documentation accurately reflects process understanding, control strategies, and commercial manufacturing activities.

MSAT Collaboration & Technical Alignment

• Partner with MSAT SMEs to capture, structure, and articulate detailed product and process knowledge.
• Maintain consistency across internal technical documentation and global regulatory filings.
• Serve as a documentation authority, advising on structure, detail, and clarity.

Global Regulatory CMC Support

• Provide hands?on authorship for global submissions (FDA, EMA, international agencies).
• Prepare and refine technically complex responses to health authority questions.
• Support inspection preparation through high?quality, inspection?facing documents.

Lifecycle & Change Management Support

• Manage CMC documentation updates to support post?approval changes.
• Ensure global consistency across historical and current filings.
• Support documentation for change controls, deviations, investigations, and process changes.

External Partner / CMO Collaboration

• Work directly with CMOs to obtain and integrate technical information.
• Support onboarding of new manufacturing partners with accurate documentation capture.

Quality, Compliance & Independence

• Deliver inspection?ready, compliant submissions aligned with ICH, GMP, and global CMC guidelines.
• Apply and refine templates, style guides, and documentation standards.
• Operate independently, managing timelines and priorities with minimal oversight.

Top Required Skills

• 15-20 years of experience in CMC documentation, regulatory writing, MSAT, or technical operations
• Extensive authorship of CMC sections for FDA, EMA, and global submissions
• Advanced degree (MS/PhD) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline
• Deep understanding of drug substance/drug product manufacturing, control strategies, and lifecycle management
• Expert knowledge of ICH guidelines, GMP expectations, and global CMC requirements

Preferred Qualifications

• Experience supporting multi?regional submissions and post?approval changes
• Background in process chemistry or pharmaceutical development
• Proven success preparing documentation used during regulatory inspections
• Experience as a documentation authority within MSAT or Technical Operations

Key Competencies

• Expert?level technical writing and editing
• Ability to independently synthesize complex scientific information
• Strong judgment and attention to detail in a regulated environment
• Effective communication across technical and non?technical teams
• Ability to manage multiple complex documents and timelines autonomously

Location & Travel

• US Remote, or Hybrid (PA)
• Up to 5-10% travel to domestic or international manufacturing sites

Equal Opportunity

Employer:

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate.

We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate…