Global Managed Access Manager

LanceSoft Inc

Collegeville, PA

Manager, Global Managed Access

Location: 1000 Winter St, Waltham MA 02451 OR Collegeville, PA 19426

Duration: 12-month contract Possibility to extend

Hybrid, onsite 2 days per week in Waltham or Upper Providence (Waltham is preference) EST timezone

Monday to Friday 7am start to keep up with the UK team

Job Description

Work with internal stakeholders to provide operational leadership for oncology expanded access/compassionate programs including plans and strategies for footprint, drug supply, regulatory coordination, physician oversight, vendor set up and management, safety reporting, and other related activities accordance with CLIENT Policies and SOPs
Oversee the management of vendors associated with access programs
Set up operations to ensure rapid response to requests from physicians regarding patient access to EAP/CU programs
Provide regular status updates on program utilization to internal stakeholders
Provide operational input and assistance when required
Establish strong relationships with all stakeholders, including Global Medical Affairs colleagues, Supply team, LOCs, physicians, program managers, regulatory and safety teams as well as external vendors

Requirements

BSc degree in a life science related field, advanced degree preferred
Demonstrable, varied, and progressive experience in a professional scientific or clinical role, either in Medical Affairs/Clinical Operations/Managed access supply or at a relevant institution or vendor
Experience managing an individual compassionate use program or Expanded Access Program, or proven experience managing clinical research studies in a professional setting
Oncology medical or scientific experience very much desired
Experience managing Vendors
Demonstrated knowledge of protocol design in oncology studies.
Strong planning and project management skills

Clinical trial experience
Experience dealing with global regulations
Pharma experience is key
5+ years of experience across the board in pharma or research

Apply

Vacancy posted 26 days ago

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