Technical Writer
Job Summary:
Number of resources: 4
Location: Onshore (US Eastern Time Hours)
Duration: 6 months with a potential extension of another 6 months
Responsibility for developing and revising procedures (Procedures, Work Instructions, Job Aides) with input from cross-functional teams, subject matter experts, and the Global Process Owners. This role requires a deep understanding of GxP practices, particularly in Document Management, and Learning Management systems.
Key Responsibilities:
- Create and revise high quality procedures under the guidance of the Global Process owner (GPO).
- Incorporate all technical and business process requirements into clear, concise and compliant procedural documents.
- Work closely with cross-functional teams to gather information and ensure documentation meets needs.
- Utilize technical writing best practices. Collaborate with project team, subject matter experts to gather and validate information.
- Ensure that all procedures and documents comply with GxP (Good Practice) standards.
- Conduct regular audits to verify compliance and identify areas for improvement.
- Develop training materials and user guides to support the implementation of new procedures.
- Collaborate with the Learning and Development team to ensure that training content is effective and up-to-date.
- Communicate effectively with cross-functional teams, including Quality, Operations, and IT.
Qualifications:
- Industry Experience: 3+ years of experience in the Pharma and/or Consumer Health industry.
- Strong understanding of regulatory requirements and industry standards.
- Previous experience in Document Management systems (e.g., Veeva, Documentum, Tru) to create, store, and manage documents is preferred.
- Previous experience with Document Management, GxP Records and Learning Management processes in regulated business is preferred.
Technical Writing Experience:
- 3+ years of experience in technical writing, with a focus on procedure development and revision.
- Proven ability to write clear, concise, and accurate technical documents.
- Strong knowledge of Microsoft Office Suite (Word, Excel, PowerPoint).
Language Proficiency:
- High proficiency in English, both written and verbal.
Soft Skills:
- Excellent communication and interpersonal skills.
- Structured and well-organized ○ Strong attention to detail and ability to manage multiple projects simultaneously.
- Ability to work independently and as part of a team.
Education:
- Bachelor’s degree in English, Communications, Technical Writing, or a related field. Advanced degree or certification in Technical Writing is a plus.
Job Type: Contract
Schedule:
- 8 hour shift
Work Location: Remote