What are the responsibilities and job description for the CMC Writer / Project Manager position at TekWissen ®?
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
Pay Rate: $60.00-60.00/Hourly
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.
Salary : $60