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Cmc Writing Jobs in Wellesley, MA (NOW HIRING)

AbbVie

Director, ADC CMC Sciences

Waltham, MA

Demonstrated excellence in writing, presentation, and overall communication. * Demonstrated excellence in leading CMC project teams. * Demonstrated ability to provide strategic direction for work ...

AbbVie

Director, ADC CMC Sciences

Waltham, MA · On-site

Demonstrated excellence in writing, presentation, and overall communication. * Demonstrated excellence in leading CMC project teams. * Demonstrated ability to provide strategic direction for work ...

AbbVie

Director, ADC CMC Sciences

Waltham, MA · On-site

$160K/yr

Demonstrated excellence in writing, presentation, and overall communication. * Demonstrated excellence in leading CMC project teams. * Demonstrated ability to provide strategic direction for work ...

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All JobsCmc Writing JobsCmc Writing Jobs in Wellesley, MA

Cmc Writing information

See Wellesley, MA salary details

$5

$33

$82

How much do cmc writing jobs pay per hour?

As of Aug 22, 2026, the average hourly pay for cmc writing in Wellesley, MA is $33.96, according to ZipRecruiter salary data. Most workers in this role earn between $21.35 and $40.87 per hour, depending on experience, location, and employer.

What is the difference between Cmc Writing vs Medical Writing?

AspectCmc WritingMedical Writing
Required CredentialsBachelor's degree in life sciences, chemistry, or related field; often certifications in pharmaceutical writingDegree in life sciences, healthcare, or related; certifications like AMWA or DIA often preferred
Work EnvironmentPharmaceutical companies, biotech firms, contract research organizations (CROs)Pharmaceutical companies, medical communication agencies, CROs
Industry UsageFocuses on Chemistry, Manufacturing, and Controls documentation for drug approvalEncompasses clinical study reports, regulatory documents, and scientific publications

In summary, Cmc Writing specializes in regulatory documentation related to drug manufacturing and chemistry, while Medical Writing covers a broader range of clinical and scientific communication. Both roles require similar credentials and often work within the pharmaceutical industry, but they focus on different aspects of drug development and documentation.

What are typical Cmc Writing job responsibilities?

Cmc Writing jobs typically involve creating, editing, and reviewing scientific or technical documentation related to chemistry, manufacturing, and control processes. Responsibilities include ensuring compliance with regulatory standards, preparing detailed reports, and collaborating with cross-functional teams. Strong writing skills, knowledge of industry regulations, and attention to detail are essential for this role.

What is a Cmc Writing?

Cmc Writing typically refers to writing related to Chemistry, Manufacturing, and Controls (CMC) in the pharmaceutical industry, involving documentation for drug development and regulatory submissions. It requires strong technical writing skills, attention to detail, and knowledge of regulatory standards. Professionals in this field often work with scientific data, validation protocols, and compliance documentation.

What job categories do people searching Cmc Writing jobs in Wellesley, MA look for?

The top searched job categories for Cmc Writing jobs in Wellesley, MA are:

Cmc Writing jobs near you
Infographic showing various Cmc Writing job openings in Wellesley, MA as of August 2026, with employment types broken down into 84% Full Time, 5% Part Time, and 11% Contract. Highlights an 79% In-person, and 21% Remote job distribution, with an average salary of $70,641 per year, or $34 per hour.

Director, Regulatory CMC

Genetix Biotherapeutics

Somerville, MA • Hybrid

$163K - $216K/yr

Full-time

Re-posted 8 days ago

Job description

The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for approved and late-stage gene therapy products, with a primary focus on lifecycle management, change management, and regulatory compliance. This role supports the development and delivery of post-approval regulatory strategies and ensures effective implementation of manufacturing, analytical, and control changes across global markets.

The Director partners closely with Technical Operations, Quality, and Supply Chain to ensure alignment between regulatory requirements and operational execution. This individual contributes to regulatory interactions with health authorities and plays a key role in supporting post-approval submissions, inspection readiness, and ongoing compliance activities.

This is a full-time hybrid position (3 days a week) in our Somerville, Massachusetts office. 

Specific Job Duties
  • Lead execution of post-approval CMC lifecycle management activities, including preparation and submission of global supplements, variations, and annual reports
  • Support development and implementation of CMC change management strategies, assessing manufacturing, analytical, raw material, facility, and control changes and recommending appropriate regulatory pathways
  • Manage regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness, including drafting responses to health authority questions and commitments
  • Contribute to regulatory interactions with global health authorities (e.g., FDA, EMA), including support for meetings, information requests, and inspection activities
  • Partner with Technical Operations, Quality, Supply Chain, and Program Teams to ensure regulatory strategy aligns with operational plans and timelines
  • Author and review post-approval CMC documentation, ensuring consistency with approved dossiers and global regulatory requirements
  • Ensure adherence to global CMC regulatory standards and guidance (FDA, EMA, ICH) applicable to commercial and post-approval gene therapy products
  • Monitor and apply regulatory intelligence related to post-approval expectations, emerging guidance, and inspection trends
  • Provide mentorship and guidance to junior Regulatory CMC team members as appropriate
  • Represent Regulatory CMC on cross-functional teams and provide clear, risk-based regulatory input to support decision-making
Required Education, Experience, or Qualifications
  • Bachelor's or Master's degree in life sciences (biochemistry, chemistry, biology, biochemical engineering, or related field)
  • Minimum of 10-12 years of biopharmaceutical industry experience, with relevant experience in CMC regulatory affairs for biologics or gene therapy products
  • Experience supporting post-approval CMC submissions (e.g., supplements, variations, annual reports) and regulatory interactions
  • Strong understanding of commercial manufacturing and lifecycle management for complex biologics and/or gene therapy products
  • Solid knowledge of GMP, CMC regulatory requirements, and global regulatory frameworks (FDA, EMA, ICH)
  • Strong written and verbal communication skills, with the ability to translate technical information into clear regulatory documentation
  • Demonstrated ability to work effectively in cross-functional, matrixed environments
  • Strong organizational skills and ability to manage multiple priorities in a fast-paced environment

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