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CMC Writer (Paramus)
CMC Writer (Paramus)TekWissen • Paramus, NJ, US
CMC Writer (Paramus)

CMC Writer (Paramus)

TekWissen • Paramus, NJ, US
1 day ago
Job type
  • Part-time
  • Temporary
Job description

Job Title : CMC Writer

Location : Paramus, NJ, 07652

Job Type : Temporary Assignment

Duration : 5+ Months

Work Type : Onsite

Shift : 9.00AM-5.00PM

Pay rate : - $45.00-$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 :

  • 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.

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    Cmc Writer • Paramus, NJ, US

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