Job Description
Job Title: 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:
Requirements:
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 CLIENT 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
Numbers & Facts
| Location | Waltham, MA |
| Industry | Staffing/Employment Agencies |
| Salary | $1 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.