We are looking for an experienced Senior Technical Writer with a strong background in regulated Life Sciences software to join our Track Wise product documentation team. In this role, you will own the end-to-end documentation lifecycle for Track Wise Manufacturing (MES) and Track Wise Quality (QMS) — producing content that is technically accurate, regulatory-aware, and genuinely useful to pharmaceutical and biotech customers operating in GxP-regulated environments.

You will work closely with Product Management, Engineering, UX, and Validation teams to translate complex platform capabilities — spanning batch manufacturing, electronic batch records, quality events, CAPA, and OEE — into clear, structured documentation for administrators, operators, IT teams, and validation engineers.

Qualification & Experience:

• Education: Bachelor's degree or higher in Technical Communication, Computer Science, Life Sciences, Pharmacy, Engineering, or a related field.
• Experience: Minimum 3 years of technical writing experience, with at least 2 years in a Life Sciences software environment (MES, QMS, LIMS, or ERP for pharma/biotech).
• Domain Exposure: Demonstrable experience documenting regulated software used in pharmaceutical or biotech manufacturing. Hands-on familiarity with MES or QMS platforms is strongly preferred.
• Portfolio: A strong portfolio of technical documentation samples relevant to Life Sciences software or regulated manufacturing environments is required.
• Languages: Excellent written and spoken English. Additional languages are an advantage.

Key Accountabilities & Deliverables.

Documentation Planning & Ownership

• Own the documentation plan for assigned Track Wise product releases — scoping deliverables, estimating effort, and tracking progress against release milestones.
• Maintain a documentation roadmap aligned with the product roadmap, anticipating new feature areas and regulatory documentation requirements in advance.
• Define and enforce documentation standards, templates, and style guide compliance across all content produced by the team.

Content Development

• Plan, write, and maintain installation guides, configuration manuals, user guides, release notes, API documentation, and validation support packages (VSPs) for Track Wise Manufacturing and Track Wise Quality.
• Produce GxP-relevant documentation including User Requirement Specifications (URS) support content, Functional Specifications (FS) documentation aids, and Installation/Operational Qualification (IQ/OQ) guide templates.
• Author structured content using DITA or Mad Cap Flare, applying topic-based authoring principles to maximise content reuse across product lines.
• Translate complex technical concepts — including ISA-88/ISA-95 workflows, 21 CFR Part 11 controls, EU Annex 11 compliance features, and electronic signature mechanisms — into clear, accessible documentation for diverse audiences.

Stakeholder Engagement

• Lead structured knowledge-gathering sessions with Subject Matter Experts (SMEs) across Engineering, Product Management, Regulatory, and Customer Success to extract technical information and convert it into high-quality documentation.
• Facilitate content reviews with SMEs, QA reviewers, and regulatory consultants; manage feedback cycles and maintain version-controlled review records.
• Collaborate with the UX team to align in-product help content, tooltips, and UI labels with broader documentation.
• Partner with Customer Success and Implementation teams to understand documentation gaps identified during customer go-lives and address them proactively.