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Daiichi Sankyo US · 23 hours ago

Manager, Project Lead, Program Management (Clinical Trial Supply)

Basking Ridge, NJ

Full-time

Onsite

Senior Level

$116K/yr - $175K/yr

7+ years exp

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care. The Manager, Project Lead, Program Management role is responsible for enabling the on-time delivery of clinical supplies and supporting project management leads by developing study supply plans and managing work streams with service providers.

Health CareTherapeuticsWellness

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Develops and updates Study Supply Plans in close communication with CSO project Management Lead

Responsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs

Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel

Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems

Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation

Vendor Management –supports Person in Plant (PIP) activities when packaging operations for DSI are in-process

Supports investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship

Assists in the creation of SOP’s and work instructions specific to CSO Supply Planning as requested

Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents

Supports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and agreed to by management

Qualification

Clinical Supply ManagementPharmaceutical DevelopmentProject ManagementOncology ExperienceSupply Planning ToolsBachelor's DegreeCommunication Skills

Required

Bachelor's Degree

Bachelor's degree in Science or related field. Extensive experience will be considered in lieu of an advanced degree required

7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development

Ability to travel up to 10% of the time. Overnight / single-day travel will be required to go to outsourcing vendors from time to time infrequently

Preferred

Oncology Experience

Creation of Supply Planning tools

Company

Daiichi Sankyo US

Glassdoor4.0

Daiichi Sankyo US is a pharmaceutical company delivering innovative research, solutions, and treatments to improve health.

Founded in 2005

Basking Ridge, New Jersey, USA

10001+ employees

https://daiichisankyo.us

H1B Sponsorship

Daiichi Sankyo US has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (32)

2024 (25)

2023 (19)

2022 (12)

2021 (7)

2020 (6)