Global Managed Access Manager

LanceSoft Inc

Waltham, MA

Apply

JOB DETAILS

SALARY

$1–$95.43 Per Hour

SKILLS

Biology, Biotech and Pharmaceutical, Clinical Research, Clinical Trial, Customer Relations, Leadership, Medical Affairs, Oncology, Program Planning, Project/Program Management, Protocol Design, Regulations, Standard Operating Procedures (SOP), Strategic Planning, Vendor/Supplier Management

LOCATION

Waltham, MA

POSTED

21 days ago

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:

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

About the Company

LanceSoft Inc

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.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/