Senior Clinical Supplies Manager - New Jersey, NJ | Biospace
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Senior Clinical Supplies Manager

Omega Management Group

Location:
New Jersey, NJ
Posted Date:
11/16/2016
Position Type:
Full time
Job Code:
1175
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Manages the clinical supplies supply chain including activities focused on of approval and selection of contract manufacturing & packaging organizations, manufacturing, packaging and labeling operations and the reconciliation and destruction of clinical supplies materials. Accountable for effectively managing clinical supplies based on study timing, and in accordance with protocols, cGMP/GMP, GCP, ICH, FDA and any applicable international, federal and/or local laws and regulations and standard operating procedures.
Job Description
•   Drive the capability and feasibility assessment of contract manufacturing & packaging
organizations
•   Coordinate functional and cross-functional activities within the company (CMC, Vendor Management, P&C, and Quality Assurance) and to evaluate and approve contract manufacturing & packaging organizations
•   Coordinate the preparation and approval of Quality Agreements (QAG) between Quality Assurance and the contract manufacturer, if not included in the Master Service Agreement (MSA)
•   Maintain list of current approved contract manufacturers
•   Confirm all agreements, including Confidential Disclosure Agreements (CDA), MSA, and QAG are current for all approved contract manufacturers
•   Notify appropriate parties within the company (CMC, Vendor Management, P&C, and Clinical Operations) when a contract manufacturer has been removed from the list of approved contract packagers
•   Develop regional Clinical Supply Plans with Clinical Operation Teams
•   Participate in development of global Clinical Supply Plans with MTPE and MTPC
•   Initiate requests for the manufacture of CTM at the contract manufacturer
•   Track and report current clinical supplies activities by contract manufacturer and study
•   Develop and implement label strategy and process based on trial requirements in consultation with Clinical Science, Clinical Operations, QA, Regulatory Affairs and CMC
•   Create and finalize packaging/labeling production schedules and identify and resolve any discrepancies/issues with COT leader
•   Track, retain and report relevant departments the reconciliation, disposition, and destruction of all clinical supplies materials and related communications and reports
•   Create/participate in developing, implementing, and harmonizing clinical supplies related standard operating procedures and policies
•   Perform other departmental duties as assigned


Requirements

Qualifications
Education:
Minimum BS/BA degree in life/health sciences or related field
Professional Experience:
Minimum of 8 years experience, including a minimum of 5 years experience in labeling, packaging and distribution of clinical trial materials
Knowledge and Skills:
Must have a proven track record in the management of labeling, packaging and distribution of materials to clinical sites
Must have experience in managing diverse project activities with manufacturing facilities at different geographical location
Knowledge of FDA, ICH, GMP, GCP, and other regulatory requirements
Demonstrated knowledge of current pharmaceutical processes, packaging operations and drug development processes

Knowledge of clinical supply aspects of IND/NDA requirements; ability to present complex issues in oral and written form
Strong project management abilities.
Experience working in a multi-cultural, multi-lingual environment
Demonstrated ability to contribute successfully in a multi-disciplinary team environment / matrix organization
Competency in Windows, MS Office, Word, Excel, Power Point and other related computer software (e.g., MS Project and Lotus Notes)