Pharmaceutical Clinical Associates, LLC
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Raritan,
NJ
ESSENTIAL DUTIES AND RESPONSIBILITIES:
With assistance from Management, as needed, perform the following functions:
1. Provides day to day QA support to Company oncology portfolio.
2. Contributes to QA strategy and implementation to support goals of the portfolio or project team:
o Is accountable for the Quality Assurance strategy role out for the therapeutic area oncology.
o Works closely with Head of Clinical Auditing, clinical and project teams to develop strategies and plans and implements on QA activities including auditing within the Company oncology portfolio.
o Is accountable for communicating and providing quality assurance strategic guidance across the oncology portfolio.
o Monitors and reviews oncology portfolio audit activities, ensures consistency in approach and reporting and tracks deliverables against the audit schedule.
o Develops and enhances QA procedures, guidance documents and audit tools covering oncology portfolio audits and identifies opportunities and proposals for clinical trial oversight improvement.
o Develops training materials and trains QA Professionals in oncology portfolio audit tools and techniques e.g. RECIST criteria.
o May participate in oncology audits to evaluate the processes and procedures and mentor/train QA Professionals.
o Interfaces with regulatory sub-teams as appropriate for compound/product stage of development.
o Actively participates in risk based QA assessments.
o Is responsible for ensuring delivery of high quality and timely information to appropriate levels of management within the oncology portfolio and developing a high level of knowledge within the portfolio.
o Provides GCP/Pharmacovigilance (PV) expertise and quality assurance expertise and leadership within the oncology portfolio.
o Maintains an independent and non-biased role in working closely with in the product/project teams.
o Prepares for and participates in global product review meetings (e.g., Europe, US).
o Is accountable for the Quality Assurance strategy role out for the therapeutic area oncology.
o Works closely with Head of Clinical Auditing, clinical and project teams to develop strategies and plans and implements on QA activities including auditing within the Company oncology portfolio.
o Is accountable for communicating and providing quality assurance strategic guidance across the oncology portfolio.
o Monitors and reviews oncology portfolio audit activities, ensures consistency in approach and reporting and tracks deliverables against the audit schedule.
Experience and Skills:
1. BS degree is required. Advanced degree desirable. Equivalent relevant professional experience may be considered.
2. At least 10 years experience in clinical QA or other clinical quality management/QC role in biomedical science, clinical development, regulatory compliance.
3. Previous experience working in projects related to oncology and/or biotherapeutica or portfolio teams highly preferred.
4. Demonstrated knowledge of ICH GCP, PV, clinical development and principles of quality assurance.
5. Demonstrated knowledge of / experience within oncology therapeutic area e.g. Imaging, RECIST criteria.
Additional Information:
Job Level: Management
Number of Openings: 1
Years of Experience: At least 7 Years
Level of Education: Any
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Raritan, NJ
Raritan, New Jersey
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