Technical Writer with GxP

Job Title: Technical Writer

Job Summary:

Location: Remote (Eastern Time Hours)

Job Type: Contract/ Hourly Full time 40 hours/week

Duration: 6 months with high potential extension

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.