Technical Writer

  • location: Bridgewater, NJ
  • type: Contract
  • salary: $41.80 - $49.18 per hour


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Job Title: Technical Writer II

Job Summary

  • The candidate must have excellent Chemistry, Manufacturing and Controls (CMC) technical writing and communication skills with a strong background in pharmaceutical manufacturing, regulatory writing or quality control/quality assurance with at least 7 years' experience in pharmaceutical manufacturing or development.

Job Responsibilities

  • Provide regulatory assessment of post-approval CMC changes for assigned FDA approved NDA drug products in accordance with current FDA regulations and guidance; author and compile CMC dossiers for NDA supplements, annual reports, phase IV IND, and DMF annual updates for assigned products in eCTD format.
  • Work closely with quality, manufacturing, regulatory and technical staff from global locations and with external contractors to communicate, coordinate and track required documentation in support of new and post-approval CMC regulatory activities.
  • Contribute to various projects by planning, writing and delivering agreed submission deliverables for US, EU and rest of world (ROW) registrations.
  • Author and create dossier content from source documentation as needed for registrations and provide writing support for technical reports.
  • Recommend table of contents for regulatory submissions.
  • Develop and contribute to regulatory strategy for successful product registration.
  • Provide and write answers to questions received from health authorities.
  • Create and author dossiers for re-registrations.
  • Ensure all dossiers are in compliance with appropriate SOPs, guidance's, GXP and ICH guidance's and maintain up to date knowledge.
  • Communicate with Quality and manufacturing site teams to request necessary content and documentation for regulatory submissions.
  • Develop and maintain skills required for dossier related software systems used and included in regulatory filings
  • Experienced with change control systems, and authoring and reviewing FDA post-approval CMC changes requiring eCTD format for submissions.
  • Worked with multi-disciplined teams in the bio-pharmaceutical industry and with internal and external partners.
  • Excellent technical writing and communication skills, attention to detail and formatting. Inform management in advance of barriers to meeting deadlines.
  • In-depth knowledge of USP/Eu. Ph. and Code of Federal Regulations (CFR).
  • Working knowledge of cGMP's

Worked with writing template tools, Documentum based or similar systems?

Education & Qualifications

  • BS/BA or MS or PhD from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy or a related field).
  • 3 plus years' experience in a pharmaceutical environment including not less than 4 years of experience with CMC regulatory related activities.
  • Expertise with MS Office, Word, Excel and Documentum based systems is crucial, experience with Visio Technical is preferred and a working knowledge of cGMP's is desired.
  • Product development, process validation and experience with CMC documentation for various dosage forms are necessary.
  • This position requires the incumbent to be highly organized, self-motivated, and able to juggle multiple priorities.
  • The desired candidate will hav
  • e the capacity to be productive with very little supervision and enjoy writing. Excellent interpersonal communication skills are required. Knowledge of the US regulatory processes is necessary and exposure to non-US regulatory activities is desired.
  • The candidate must have prior experience writing CMC technical reports or CMC regulatory content or Quality Investigations with a demonstrated ability to interact with a multi-disciplined team.
  • Experience with standardized templates and familiarity with US and International regulatory submissions is desired.
  • The ability to communicate using oral and written skills with an excellent knowledge of the English language and strong proofreading and spelling skills is required.


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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