CMC Writer / Project Manager

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.

Job Title: CMC Writer / Project Manager

Location: Paramus, NJ, 07652

Job Type: Temporary Assignment

Duration: 5+ Months

Work Type: Onsite



Shift: 9.00AM-5.00PM

Job Description:

• Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities.

• This role combines technical writing expertise with project management skills to drive Chemistry, Manufacturing, and Controls (CMC) deliverables across drug development programs.

Key Responsibilities

• Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format.

• Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals.

• Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions.

• Ensure compliance with FDA, EMA, and ICH guidelines and internal processes.

• Collaborate with cross-functional teams to gather accurate technical information.

• Identify and communicate potential regulatory risks; propose mitigation strategies.

• Support process improvement initiatives for CMC submission workflows.

Qualifications

Education:

• Bachelor's or advanced degree in Chemistry, Pharmaceutical Sciences, or related field.

Experience:

• Minimum 5 years in pharmaceutical regulatory writing or CMC project management.

• Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities.

• Familiarity with global regulatory frameworks and eCTD submissions.

• Excellent technical writing, communication, and organizational skills.

• Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint).

• Veeva Vault, Smartsheet are plus

Preferred Skills

• Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings.

• Ability to interpret and apply regulatory guidelines effectively.

• Strong project management and stakeholder communication skills.

TekWissen Group is an equal opportunity employer supporting workforce diversity.