CMC Writer Job at TekWissen ®, Paramus, NJ

V3Q0RjdmY0JMYkVNVTVJdG8xaFlJYVJFc1E9PQ==
  • TekWissen ®
  • Paramus, NJ

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:

  • 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.

Job Tags

Temporary work, Work at office, Shift work,

Similar Jobs

ABB

Full Stack Developer Intern- Summer 2026 Job at ABB

 ...reports to: IT Senior Manager Manufacturing Systems As an intern, you will have the opportunity to gain practical experience...  ...manufacturing environments, providing support for troubleshooting Develops a plan to scale the solution across manufacturing operations... 

Randstad Enterprise

Injection Mold Maintenance Mechanic Job at Randstad Enterprise

Title: Injection Mold Maintenance Mechanic Location: 256 Samuel Barnett Boulevard, New Bedford, MA, 02745 Type: Full Time Shifts: WECA Fri 10:50 PM11:00 AM & Sat 10:50 AM11:00 PM + 12 weekday shifts WECB Sat 10:50 PM11:00 AM & Sun 10:50 AM11:00 PM ...

SGS Consulting

Healthcare Consultant I - Ohio Job at SGS Consulting

 ...Quality of Care: Using holistic approach consults with case managers, supervisors, Medical...  ...to meet the member's benefits and/or healthcare needs. Utilizes influencing/ motivational...  ...Associate (CMA) role is a full-time remote telework position. Qualified candidates... 

Total Quality Logistics

Inside Sales Representative Job at Total Quality Logistics

 ...motivated individuals to join our award-winning team. This isnt just sales; it is far more. You'll build relationships, negotiate freight...  ...Partner with a TQL broker to manage their account, secure carriers for freight and handle all necessary documentation... 

Lamplighter Brewing Co.

Director of Operations Job at Lamplighter Brewing Co.

 ...taprooms and an in-house coffee shop in downtown Cambridge. Were dedicated to producing high-quality, creative, and flavor-driven beers, specializing in New England IPAs, barrel-aged sours, and unique seasonal releases. Our team is collaborative, passionate, and committed...