Pharmaceutical Clinical Associates, LLC
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Central,
MD
Responsible for coordinating the initial creation and subsequent revisions of CDSs, USPIs and other regional labeling for assigned products. Ensures that CDSs, USPIs and corresponding regional prescribing information provide all essential information for the safe and effective use of the product.
Major Duties and Responsibilities (including supervising others):
1. Lead cross-functional teams in the development and lifetime maintenance of the CDS, USPI and other regional labeling for assigned therapeutic area(s)
2. Provide tactical guidance to Labeling Working Groups/Global Labeling Committee regarding language, placement, and regulatory content detail for regional prescribing information and CDSs
3. Provide precedent searches and comparison matrices
4. Manage corporate review and approval of all CDSs, USPIs and other regional prescribing information
5. Issue CDSs and monitor implementation across regions
6. Ensure consistency in prescribing information across products and therapeutic areas
7. Ensure corporate quality standards for prescribing information are met
8. Maintain repository of all labeling documents, ensuring version control and document integrity of internal draft, Agency-submitted and Agency-approved labels
9. Represent functional expertise at all relevant department meetings
10. Participate in the development and maintenance of policies, SOPs, and associated documents relating to corporate oversight of regional prescribing information
11. Train process contributors on corporate labeling practices
12. Provide comments regarding regional labeling guidance changes
13. Liaise with senior management as needed to resolve critical labeling issues
14. Ensure regional submission timelines are met as appropriate
15. Provide guidance to the junior regulatory staff as need arises
16. Perform functions of significant scope with minimal supervision
17. Assist in other regulatory activities as required
Experience and Skills:
Position Requirements Experience: A minimum of 4 years of increasing documented success in regulatory
affairs (preferably in labeling) with an additional 5 years or more in a
relevant field of pharmaceuticals/biotechnology. Work experience in a biopharmaceutical arena is highly desirable.
Experience working in a GMP pharmaceutical environmental. Competent
knowledge of FDA regulations (current Code of Federal Regulations and FDA
Guidances) and ICH guidelines preferred. Thorough understanding of and demonstrated ability to apply US/EU regulatory guidelines pertaining to product labeling, and CIOMS III/ V guidelines.
Additional Information:
Job Level: Management
Number of Openings: 1
Years of Experience: At least 5 Years
Level of Education: BA/BS
Salary: $ 95,000 to 110,000
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.
Central, MD
Central, Maryland
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