Senior TMF & PV Documentation Excellence Lead

Regulatory Jobs; Cambridge (MA); Hybrid; USD 137,000 - 215,000; Full time

Job summary

Takeda is seeking a Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence in a hybrid role in Cambridge, MA. You will oversee TMF and PV documentation, drive inspection readiness, and coordinate global records management initiatives across Study teams and vendors.

Responsibilities include leading acquisition/divestment TMF activities, managing archival operations, and advancing automated documentation improvements to ensure compliance and efficiency.

Qualifications

• Required scientific or allied health/medical degree (BSc/BA) or equivalent experience.
• Experience with TMF/eTMF and PV documentation across pharma/biotech/CRO environments.
• Knowledge of ICH E6 (R2/R3), 21 CFR Part 11, EU CTR and GVP guidance.
• Familiarity with CDISC TMF Reference Model and TMF plans/EDLs.

Responsibilities

• Manage TMF and PV documentation activities across the portfolio.
• Collaborate with cross-functional teams and external partners to maintain records excellence.
• Coordinate TMF processes and inspection readiness strategies.
• Lead TMF activities for acquisitions/divestments including due diligence and migrations.
• Oversee physical records room operations and archival facilities.
• Manage electronic records in Takeda CMS and third-party databases.
• Provide project management and inspection support for audits.
• Identify gaps and elevate risks related to TMF/PV documentation quality.

Skills

TMF/eTMF knowledge

PV documentation

Global cross-functional collaboration

Documentation governance

Education

BSc/BA in science or equivalent

Job description

Takeda is seeking a Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence in a hybrid role in Cambridge, MA. You will oversee TMF and PV documentation, drive inspection readiness, and coordinate global records management initiatives across Study teams and vendors.

Responsibilities include leading acquisition/divestment TMF activities, managing archival operations, and advancing automated documentation improvements to ensure compliance and efficiency.