This is a remote position.
Job Title: 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.
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