JOB DESCRIPTION:
Primary Job Function:
The role supports the Global Preclinical & Product Safety (GPPS) team by managing critical documentation and administrative functions essential for efficient department operations. Responsibilities include organizing and maintaining key databases, supporting all preclinical project activities, ensuring adherence to quality and compliance requirements, and coordinating a range of departmental administrative tasks.
Core Job Responsibilities:
- Create and maintain the project data matrix to ensure completeness.
- Manage and organize department documentation for easy retrieval.
- Coordinate ISOTrain modules for the department.
- Support the maintenance of documentation in accordance with inhouse SOPs for quality compliance.
- Format and review preclinical modules in the dossier and upload dossier modules in DARIUS.
- Create DARIUS Object IDs for Toxicological Risk Assessments (TRA) and study reports.
- Support the team in coordinating and establishing the master Service Agreement and Confidentiality Disclosure Agreement with CROs for execution of preclinical studies.
- Coordinate the archival of all project documents and reports.
- Manage the Abbott Drug Handling Committee (ADHC) portal by uploading of latest employee exposure limit (EEL) summaries and Residual Dose limit (RDL) summaries.
- Monitor and track project related budget to ensure adherence.
- Coordinate with CROs and the Outsourcing team to ensure timely invoice clearance.
- Coordinating with finance on - WBS No., budget tracking in MRA, monthly commitment updates and ad-hoc finance queries.
- Provide administrative support to GPPS team including:
- Travel budget estimation, approval, and reservations.
- Scheduling meetings for leadership and onboarding new hires
- Managing staff welfare activities and expense submissions.
- Facilitating logistics and support during global stakeholder visits.
- Coordinator for DocuSign processing
Supervisory/Management Responsibilities: NA
Direct Reports: No
Indirect Reports: No
Position Accountability/Scope:
- GPPS Audit documentation
- GPPS data matrix
- GPPS Databases
- Admin support
Minimum Education:
- Graduation with more than 5 year experience as documentation specialist
Minimum Experience/Training Required:
- Proficient in MS Office, with advanced skills in Excel experience with Power BI is preferred
- Expert in creating structured, clear, and concise technical documents, including SOPs, study reports, work instructions, training materials, and regulatoryrequired documentation
- Proficient in drafting templates, checklists, and documentation frameworks to improve departmental efficiency
- Proficient in documentation tools and platforms such as DARIUS, ISOTrain, electronic documentation systems, and document management portals
- Experienced in formatting, proofreading, and qualitychecking documents, ensuring consistency, clarity, and compliance with internal SOPs
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Administrative Support
DIVISION:
EPD Established Pharma
LOCATION:
India Mumbai : BKC Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
