TekWissen ®
Job Title: CMC Writer
Location: Paramus, NJ, 07652
Job Type: Temporary Assignment
Duration: 5+ Months
Work Type: Onsite
Shift: 9.00AM-5.00PM
Base pay range $45.00/hr - $47.00/hr
Overview TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.
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.
Senior level: Associate
Employment type: Contract
Job function: Management and Other
Industries: Investment Management and Strategic Management Services
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Location: Paramus, NJ, 07652
Job Type: Temporary Assignment
Duration: 5+ Months
Work Type: Onsite
Shift: 9.00AM-5.00PM
Base pay range $45.00/hr - $47.00/hr
Overview TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.
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.
Senior level: Associate
Employment type: Contract
Job function: Management and Other
Industries: Investment Management and Strategic Management Services
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