Technical Writer - Amaris Consulting : Job Details

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.