Senior TMF & PV Documentation Excellence Lead

Takeda Pharmaceutical Company Limited; Adams (MA); Hybrid; USD 137,000 - 215,000; Full time

Job summary

Takeda Pharmaceutical Company Limited in Cambridge, MA is seeking a Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence in a hybrid role. You will lead TMF/eTMF and PV documentation, ensuring inspection readiness and regulatory compliance across global trials.

Candidates should bring 6+ years in pharma/biotech/CRO with TMF experience, strong regulatory knowledge, and proven cross-functional collaboration.

Qualifications

• Minimum 6+ years in pharma/biotech/CRO with TMF/eTMF and PV documentation.
• Demonstrated collaboration with global teams, vendors and cross-functional stakeholders.
• Strong regulatory knowledge: ICH E6, 21 CFR Part 11, EU CTR and GVP.
• Solid understanding of CDISC TMF Reference Model and TMF Plans/EDLs.
• Experience in records management programs and governance.

Responsibilities

• Oversee TMF/PV documentation activities across the portfolio as primary contact with Clinical Trial Delivery, Medical and PV functions.
• Coordinate TMF processes and inspection readiness strategies with study teams and Documentation Excellence.
• Lead end-to-end TMF activities for acquisitions and divestments, including due diligence and migrations.
• Maintain physical records room operations and manage electronic records in CMS and third-party databases.
• Support regulatory inspections and internal audits; provide inspection readiness and audit support.

Skills

TMF/eTMF expertise

PV documentation

Regulatory knowledge

GxP / ICH compliance

Cross-functional collaboration

Project management

SOPs / process improvement

ALCOA+ / data integrity

Education

BSc/BA or equivalent in life sciences

Tools

eTMF platforms

PV systems

Content management systems

Regulatory databases

Job description

Takeda Pharmaceutical Company Limited in Cambridge, MA is seeking a Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence in a hybrid role. You will lead TMF/eTMF and PV documentation, ensuring inspection readiness and regulatory compliance across global trials.

Candidates should bring 6+ years in pharma/biotech/CRO with TMF experience, strong regulatory knowledge, and proven cross-functional collaboration.