Amaris Consulting
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.
Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.
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.
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.
Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.
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.