Technical Documentation Specialist – Global Preclinical & Product Safety (GPPS)
Location: Mumbai, India
Category: Business Support
Employment Type: Full-Time
ThePharmaDaily.com is featuring an exciting opportunity for a highly organized and detail-oriented Technical Documentation Specialist to support Global Preclinical & Product Safety (GPPS) operations in Mumbai. This role is ideal for professionals with strong documentation expertise, regulatory understanding, and cross-functional coordination experience within pharmaceutical or life sciences environments.
Job Overview
The Technical Documentation Specialist will play a critical role in managing, maintaining, and optimizing documentation systems that support preclinical development activities. The position ensures quality compliance, regulatory alignment, audit readiness, and seamless coordination between internal stakeholders, CROs, and finance teams.
This role demands technical documentation expertise, advanced data management skills, and operational excellence in regulated environments.
Key Responsibilities
Documentation & Compliance Management
Create and maintain comprehensive project data matrices to ensure accuracy and completeness.
Organize and manage departmental documentation for efficient retrieval and audit readiness.
Maintain documentation in accordance with internal SOPs and quality compliance standards.
Format, review, and upload preclinical dossier modules in DARIUS.
Generate DARIUS Object IDs for Toxicological Risk Assessments (TRA) and study reports.
Coordinate archival of project documents and reports.
Manage ISOTrain modules for departmental compliance.
Oversee DocuSign coordination for documentation workflows.
Regulatory & Preclinical Support
Support master Service Agreements (MSA) and Confidentiality Disclosure Agreements (CDA) with CROs.
Manage the Abbott Drug Handling Committee (ADHC) portal by uploading Employee Exposure Limit (EEL) and Residual Dose Limit (RDL) summaries.
Support GPPS audit documentation and database management.
Financial & Budget Coordination
Monitor and track project-related budgets.
Coordinate with CROs and Outsourcing teams for timely invoice processing.
Collaborate with finance on WBS numbers, budget tracking in MRA, monthly commitments, and ad-hoc financial queries.
Administrative & Operational Support
Manage travel budgeting, approvals, and reservations.
Schedule leadership meetings and support onboarding of new hires.
Coordinate staff welfare initiatives and expense submissions.
Facilitate logistics for global stakeholder visits.
Experience Required
Minimum 5+ years of experience as a Documentation Specialist in pharmaceutical, biotech, CRO, or regulated life sciences industries.
Proven experience supporting preclinical, product safety, or regulatory documentation functions.
Educational Qualification
Graduation in Life Sciences, Pharmacy, Biotechnology, or a related discipline.
Required Skills & Technical Expertise
Advanced proficiency in MS Office, especially Excel; Power BI knowledge preferred.
Strong experience in drafting and structuring:
SOPs
Study reports
Work instructions
Training materials
Regulatory documentation
Expertise in documentation platforms such as DARIUS, ISOTrain, electronic documentation systems, and document management portals.
Experience in formatting, proofreading, and quality-checking technical documents for regulatory compliance.
Ability to create standardized templates, checklists, and documentation frameworks to enhance efficiency.
Role Scope & Accountability
GPPS Audit Documentation
GPPS Data Matrix Management
Departmental Database Oversight
Administrative and Cross-Functional Coordination
Why This Role Matters
This position is pivotal in ensuring documentation integrity, regulatory compliance, and operational efficiency across global preclinical safety projects. The role directly supports data accuracy, audit readiness, financial governance, and cross-functional collaboration.
For more pharmaceutical, regulatory affairs, quality assurance, and life sciences career opportunities, explore global listings on ThePharmaDaily.com.
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