CMC Technical Writer

Barrington James; United States; On-site; USD 70,000 - 151,000; Full time

Job summary

A leading company in pharmaceutical manufacturing seeks a Recruitment Consultant specializing in Quality for the US and Canada. This mid-senior level contractor role involves developing technical documentation and regulatory submissions. Candidates should possess a relevant BS degree and 3-5 years of experience in CMC documentation, demonstrating strong technical writing skills.

Qualifications

• 3-5 years of experience in authoring CMC sections.
• Understanding of CMC manufacturing documentation requirements.
• Demonstrated competency in clear and concise technical writing.

Responsibilities

• Develop and author CMC technical documents and summary reports.
• Collaborate with QA and RA for regulatory submissions.
• Support the operation and review process for regulatory documents.

Skills

Technical Writing

Regulatory Compliance

Collaboration

Education

BS in Chemistry

BS in Pharmaceutical Sciences

BS in Regulatory Affairs

Job description

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Recruitment Consultant - Quality - US & Canada

Responsibilities & Job Description (demand:10-20 h/week approximately)

• Develop and author CMC technical documents and summary reports for development and regulatory submissions
• Collaborate with QA and RA to compose responses to meet regulatory requirements including supplements, variations, and annual reports
• Author and assess change controls for regulatory impact
• Author technical reports, source documents, position papers, white papers or SOPs
• Supports integrated review process for authored sections
• Support the operation of the review process and creates updated draft for next phase review
• Participate in initiatives involved with tracking CMC related documents
• Support the logistical process for regulatory submissions of CMC documents
• Assist in the facilitation of review, verification and submission-ready CMC sections

Requirements

• BS in Chemistry, Pharmaceutical sciences, Regulatory Affairs or other relevant fields.
• 3-5 years of experience in authoring CMC sections of regulatory filings.
• Experience working closely with departments such as Process Chemistry, Analytical and Regulatory Affairs.
• Demonstrated competency in clear and concise technical writing ability
• Understanding of CMC manufacturing documentation requirements for small molecule products.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Science and Manufacturing

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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