CMC Writer Project Manager

Paramus, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 6 hours ago

Vacancies: 1 Vacancy

Job Summary

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:

Bachelors 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.

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 Wo...