Technical Writer Job at Amaris Consulting, Lititz, PA

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  • Amaris Consulting
  • Lititz, PA

Job Description

We are seeking a Technical Writer with pharmaceutical industry experience to join our client’s team in Lititz, Pennsylvania . This is an on-site position requiring strong writing skills, attention to detail, and a solid understanding of regulatory and GMP documentation standards.

Key Responsibilities:

  • Write, review, and edit technical documents, including SOPs, batch records, protocols, reports, and manuals.
  • Ensure documents comply with internal standards, GMP guidelines, and applicable regulatory requirements (FDA, EMA, Health Canada).
  • Translate complex scientific and technical information into clear, concise, and compliant documentation.
  • Collaborate closely with subject matter experts (SMEs), regulatory affairs, quality assurance, and manufacturing teams.
  • Manage documentation lifecycle using electronic document management systems (e.g., Veeva Vault, MasterControl)

Profile Requirements:

Education:

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, Biochemistry, or English/Communications with relevant scientific writing experience.

Experience:

  • Minimum 3 years of experience in the pharmaceutical, biotech, or medical device industry (5+ years preferred).
  • Knowledge of ICH guidelines, GxP standards, and document control best practices.
  • Familiarity with document management systems and regulatory documentation.

Skills:

  • Excellent written and verbal communication skills in English.
  • Strong grammar, editing, and organizational abilities.
  • Detail-oriented, autonomous, and capable of managing multiple priorities.
  • Team player with proven ability to collaborate cross-functionally.

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