Clinical Supplies Project Specialist, Clinical Operations

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
September 25 2019
Ref
R1784
Discipline
Life Sciences, Biology
Organization Type
Biotech
The Role:

Moderna is seeking a Clinical Supplies Project Specialist to assist our Clinical Supplies Project Managers and to work with packaging and labeling and IRT vendors and CROs. This position works collaboratively across several therapeutic area teams as well as cross functionally to support study needs. This successful candidate will be skilled at fulfilling the needs of our projects with attention to detail and with a collaborative outlook.

Here's What You'll Do:
  • Work with our Clinical Supply Project Managers to facilitate logistics as required to support the labeling, packaging and shipment of clinical drug supplies to depots/investigative sites as well as other clinical supplies as necessary.
  • Execute user acceptance testing for IRT systems.
  • Monitor inventory and distribution activities.
  • Monitor packaging, labeling, distribution work being done with third party vendors to ensure goals are met.
  • Ensures the work is done in compliance to relevant SOPs
  • Maintains collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements.
  • Monitors and tracks shipments to ensure smooth transit through the logistical path -including international shipping.
  • Assist in oversight activities performed by third part vendor including procurement, labeling performance, on-time delivery, quality, improvement initiatives and issue resolution.
  • Assist in the development of the pharmacy manual in conjunction with relevant cross functional leads
  • Assist in the development of drug supply training materials for investigational sites


Here's What You'll Bring to the Table:
  • One - three years of clinical drug supply management, clinical supply chain, clinical supplies, hospital pharmacy, pharmacy experience or equivalent required
  • Bachelor's degree in a science-based subject is preferred
  • Creative, capable problem-solver
  • Prior Cold Chain packaging, labeling, distribution experience preferred
  • IRT design and management experience preferred
  • Proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)
  • Experience with Clinical Supply Inventory Management systems preferred
  • Attention to detail
  • Experience in maintaining relationships with vendors preferred


Here's What We'll Bring to the Table:
  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-KF1

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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