Technical Writer ( {{city}})
We are seeking a Technical Writer with pharmaceutical industry experience to join our clients 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:
- Bachelors or Masters 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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