Technical Source is currently searching for a Regulatory Technical Writer for our pharmaceutical manufacturing client in the Rocky Mount, NCarea. The qualified candidate will have experience in technical writing and approving FDA submittal packages for drug manufacturing processes.

Responsibilities of the Regulatory Technical Writer include:

• Technical writing, reviewing, and approval of FDA regulatory submission documentation
• Drive activities to completion and facilitate reconciliation of comments during Peer Review with Technical SMEs and/or applicable groups as needed
• Collaborate with technical SME and provide guidance during authoring of FDA submissions

Qualifications of the Regulatory Technical Writer include:

• 1+ years of experience authoring and approving FDA documentation and submissions
• Experience with FDA documentation submission process
• Bachelor’s or Associates degree in related field preferred

Compensation for the Regulatory Technical Writer includes:

• $65,000-95,000 based on experience and fit
• Strong benefits, medical, dental and vision provided
• No Corp to Corp or Visa sponsorships at this time

Key Words: 21 CFR Part 11, AIQ, AOQ, GAMP5, GMP, pharmaceutical, Computer System Validation, CSV, remediation, quality systems, process, tanks, filling lines, manufacturing, bioreactor, aseptic, sterile, fill, finish, upstream, downstream, FDA, regulatory, Validation, IQ, OQ, PQ, Engineering, automation, pharma, commissioning, qualification, Quality control, quality assurance, technical documentation, document control, workflow, files, document management, auditing, engineering, pharma, pharmaceutical, contract to hire, contract, permanent, full time, benefits, 401K, direct hire, cell culture, gene therapy, temperature mapping,

Job Type: Full-time

Pay: $70,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• Pharmaceutical: 1 year (Required)

Work Location: One location

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