Pharmaceutical Clinical Associates, LLC
-
Raritan,
NJ
This position is responsible for coordinating, tracking and optimizing the interactions of the Clinical Pharmacology group with other functional areas within company ( i.e.- non-clinical, clinical, regulatory, medical writing and manufacturing.) The candidate must be able to work within a team, as well as independently, to understand, prioritize and efficiently assist in coordinating Clinical Pharmacology resources so as to address critical needs within the Company.
ESSENTIAL DUTIES AND
RESPONSIBILITIES
Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.
1 Attend Team meetings to provide input and understand needs of teams with respect to Clinical Pharmacology deliverables. Acts as Clinical Pharmacology advocate for the drug development projects throughout the organization.
2 Organize, Prioritize and Track Clincal Pharmacology Projects, both internal and external.
3 Prepare reports and Facilitate delivery of reports and documents necessary for completion of regulatory submissions.
Manage Department outsourcing efforts including bid requests, contractor selection, and liaison with contractors, verify accuracy of quotes, summarize responses, and process contractual documents. Coordinate results transfer and reporting.
4 Coordinate and Plan, together with Lab Personnel capital and expense projects.
5 Serve as Department archivist. Receive, file and maintain documents necessary for departmental reference and function in local archives.
Experience and Skills:
ESSENTIAL KNOWLEDGE,
SKILLS, EXPERIENCE
1 B.S. Required, M.S. or Ph.D. in a biological science or pharmacologic discipline preferred
2 5+ years experience in a clinical research laboratory, biopharmaceutical industry or basic research laboratory preferred.
3 Excellent verbal and written skills. Ability to communicate across functional areas (clinical, regulatory and manufacturing).
Experience in IND/NDA/BLA submissions
4 Ability to work within a team environment and willingness to contribute to the overall goals of the Clinical Pharmacology group.
5 Familiarity with laboratory information management systems (Watson), Laboratory Automation (Biomek) and data analysis software (Winonlin, JMP)
6 Ability to work independently as well as direct support lab personnel.
7 Proficiency in managing multiple tasks and priorities
8 Good problem solving and decision making skills
9 Ability to make things happen via influence in a fully matrixed management environment (no direct reporting relationships)
Contact Dan Meyer 704.399.4666
dan@pharmca.com
**Do to the volume of resumes only qualified candidates will be contacted
Additional Information:
Job Level: Management
Number of Openings: 1
Years of Experience: At least 5 Years
Level of Education: Masters Degree
Salary: $ 95,000 to 100,000
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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