Job Title: Senior Technical Writer Digital Compliance / SDLC
Experience: 10+ Years
Location: US
Work Arrangement: Remote
Job Summary
We are looking for a strong Senior Technical Writer with 10+ years of experience in technical documentation, SOP development, and compliance documentation. The ideal candidate will have a background in Pharma/Life Sciences, Digital Compliance, Quality Assurance (QA), or regulated environments.
The resource will support the development and revision of Digital Compliance, AI, and Data System Development Lifecycle (SDLC) procedures, guidance documents, training materials, and governance deliverables.
Experience with AI, Data Governance, or digital transformation initiatives is a strong plus.
Key Responsibilities
- Support Digital project teams with SDLC requirements, deliverables, and compliance expectations.
- Author, develop, revise, and maintain:
- Standard Operating Procedures (SOPs)
- Work Instructions (WIs)
- Job Aids
- Policies and guidance documents
- Templates and process documentation
- Training materials and user guides
- Develop and maintain documentation related to Digital Compliance, AI, Data, and SDLC processes.
- Work closely with Digital, IT, QA, Compliance, Data Governance, and project teams to gather requirements and translate them into clear, user-friendly documentation.
- Coordinate and track SDLC-related deliverables and governance initiatives.
- Ensure documentation aligns with applicable quality, compliance, and regulatory requirements.
- Review existing procedures and identify opportunities for improvement, standardization, and simplification.
- Develop training content, presentations, job aids, and other learning materials to support new and revised processes.
- Maintain document version control, review cycles, approvals, and change history.
- Collaborate with SMEs and stakeholders to validate technical and compliance content.
Required Skills
- 10+ years of strong Technical Writing experience.
- Proven experience authoring and maintaining SOPs, Work Instructions, Job Aids, procedures, and training documentation.
- Strong understanding of SDLC processes, documentation, governance, and compliance.
- Experience working with Digital/IT, QA, Compliance, or regulated environments.
- Excellent written and verbal communication skills.
- Ability to work with technical and non-technical stakeholders and convert complex information into clear documentation.
- Strong experience with Microsoft Word, PowerPoint, Excel, Visio, or similar documentation tools.
- Strong attention to detail and ability to manage multiple documentation initiatives simultaneously.
Preferred / Nice-to-Have Skills
- Pharmaceutical / Life Sciences industry experience.
- Experience with Digital Compliance.
- Experience with Quality Assurance (QA) / GxP environments.
- Experience with AI governance, AI compliance, or AI-related documentation.
- Experience with Data Governance / Data Management.
- Experience supporting Data or AI System Development Lifecycle (SDLC).
- Knowledge of regulated documentation and validation processes.
- Experience developing training programs and learning content.