• Clinical Pharmacy Associate

    Category Clinical Operations
    ID
    2018-1230
    Job Location
    US-MD-Rockville
    Type
    Regular Full-Time
  • Overview

    MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

     

    The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

    Summary of Position

    The Clinical Pharmacy Associate assists the Director, Clinical Pharmacy in the management and oversight of all aspects of clinical supply planning, forecasting, capacity planning, labeling/packaging, distribution and risk management for all MacroGenics’ clinical products/clinical trials. Any assigned trials may vary in size and regions involved but tend to be smaller and narrower in scope. Some supervision will likely be required when making critical decisions.

    Responsibilities

    • Assists in the management of third party vendors including CMOs, clinical supply packaging and labelling vendors, translations agencies, regional and local depots and domestic and worldwide couriers. 
    • Works closely with internal colleagues and external partners to assist in the management and oversight of clinical and ancillary supply and comparator drug inventories as required. Maintain inventories and provides study, region and country inventories for all MacroGenics clinical products.
    • Requests post-label id shipments from clinical supply vendor as required.
    • Assists in the management of clinical packaging vendors to develop the optimal packaging and resupply schemas, develop supply strategies, manage depot/site distribution/stocking requirements, and manage expiration/retest date requirements.
    • Works with Director, Clinical Pharmacy to review and develop procedures and processes to manage the growth of clinical supplies and the increasing number of clinical trials being conducted by MacroGenics
    • Assists in the review and approval of monthly invoices for assigned clinical trial activities and review for accuracy and track any discrepancies to resolution.
    • Supports systems implementation, reports and SOP creation as required.
    • Assist Clinical Pharmacy personnel with written correspondences to clinical sites or clinical supply contractors as needed.
    • Performs other Clinical Pharmacy duties as assigned.

    Qualifications

    Education

    Bachelor’s degree in a scientific discipline or related area of study

    Experience

    • Minimum of two (2) years of proven experience in related clinical supply roles in the biotech/pharmaceutical industry.
    • Minimum of two (2) years of experience with assisting or participating in the oversight of clinical supply activities including packaging, labeling, distribution, returns, accountability and destruction.
    • Experience working on both domestic and international clinical trials.

     

    Knowledge, Skills and Abilities

    • Knowledge of GCP, cGMP and GDP regulations pertaining to the procurement, manufacture, and distribution of clinical supplies is preferred
    • Knowledge of US and Global clinical labeling regulations and requirements.
    • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
    • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
    • Excellent communication and presentation skills
    • Must be proficient in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet).

    Supervisory Responsibilities

    No

    Preferred Qualifications:

    Experience with assisting in the development of project specific budgets a plus.

    Statement

    MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

    Equal Opportunity Employer/Veterans/Disabled

     

    For more information about our commitment to equal employment opportunity, please click here.

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