CMC Writer / Project Manager

TekWissen ®; Paramus (NJ); On-site; USD 68,000 - 97,000; Full time

Job summary

TekWissen Group is seeking an experienced CMC Writer / Project Manager to support regulatory submissions and produce high-quality documentation for global health authorities. This onsite role is based in Paramus, NJ, for a temporary assignment lasting 5+ months, with a 9:00 AM–5:00 PM schedule.

The role blends technical writing with project management to drive CMC deliverables across drug development programs.

Qualifications

• 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 and Smartsheet experience is a plus.

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.

Skills

Regulatory writing

Project management

Technical writing

MS Office

Cross-functional collaboration

Education

Bachelor’s or advanced degree in Chemistry/Pharmaceutical Sciences

Tools

Veeva Vault

Smartsheet

Job description

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.