Analytical SME & CMC Technical Writer

Are you a seasoned CMC expert looking for a high-impact, flexible role? A top-tier global pharmaceutical leader is seeking a remote Analytical SME & CMC Technical Writer. This fully remote position requires alignment with East Coast working hours (EST) and offers a premier opportunity to drive analytical strategies and author critical regulatory submissions.

location: Telecommute
job type: Contract
salary: $57.00 - 58.45 per hour
work hours: 9 to 5
education: Doctorate

responsibilities:

• Provide scientific leadership for phase-appropriate external drug substance (DS) and drug product (DP) analytical development, validation, and lifecycle management.
• Contribute to the development of DS/DP specifications, analytical control strategies, and stability programs for clinical trials.
• Review and author Quality Agreements, Statements of Work (SOWs), study protocols, and batch/stability data from CDMOs/CROs.
• Manage documentation workflows and global regulatory submission activities utilizing the Veeva RIM system.
• Author, review, and edit CTD Module 3 (DS and DP) documents, specifically focusing on analytical sections and Health Authority responses.

qualifications:
Required:

• Bachelor's or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline (Advanced degree preferred).
• 6+ years of pharmaceutical/biotech CMC and analytical development experience spanning NCE drug substances as well as solid and liquid formulations.
• Demonstrated experience in technical writing and authoring regulatory submissions.
• Strong familiarity with GMP regulations and global guidelines (ICH, FDA, EMA, USP, EP).

Preferred:

• Proven experience with global submissions (IND, CTA, NDA, MAA).
• Background working directly with external manufacturing or testing partners (CDMOs/CROs).

skills: Good Manufacturing Practices (GMP), European Medicines Agency (EMA), Investigational New Drug (IND), New Drug Application (NDA), Marketing Authorization Application (MAA), International Council for Harmonization (ICH), Chemistry Manufacturing and Controls (CMC)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact ....

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.