Job Description

Job Title: CMC Technical Writer

Location: Paramus NJ 07652

Job Type: Contract

Duration: 6 Months

Work Type: Hybrid

Payrate:$ 50.00 - 50.00/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:

• A Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents related to drug development, manufacturing, and quality control.
• Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
• Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions
• Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions
• Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines
• Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions.
• Assess and communicate potential regulatory risks and propose mitigation strategies
• Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications.
• Identify, communicate and escalate potential CMC regulatory issues, as needed
• Help establish regulatory CMC submission processes and procedures.
• Familiar with eCTD format submission files
• Project management skill is plus

Key Responsibilities

• Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications.
• Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements.
• Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data.
• Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing.
• Process Improvement: Help establish regulatory CMC submission processes and procedures.

Requirement

• Strong technical writing, analytical, and regulatory knowledge.
• In the pharmaceutical industry and/or pharmaceutical development, broad knowledge and understanding of regulatory submissions, manufacturing processes, analytical methods, specifications, formulation development, test method validation, process validation, and packaging validation.
• Familiar with a variety of regulatory guidelines, technical processes, and procedures related to CMC development activities.
• Strong planning and organizational skills with demonstrated ability to deliver work on time.
• Excellent written and communication skills.
• Proficient in the use of Microsoft Office Suite including Word, Excel, Outlook 365 and Access.

Qualifications

• Education: Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field.
• Experience: Prior experience in pharmaceutical or regulatory writing is preferred.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.

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