Pharmaceutical Clinical Associates, LLC
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Raritan,
NJ
GENERAL SUMMARY:
Individual will be a member of an interdisciplinary team that will provide support to the Regulatory Affairs (CMC) Organization. This team’s primary responsibility will be to provide the technical content for the Chemistry, Manufacturing and Controls (CMC) sections of all investigational drug applications (INDs, CTAs) and any required amendments, initial marketing applications along with any required supplements and amendments. Additional responsibilities include assisting the RA (CMC) Group with the compilation of the responses to the respective health authorities resulting from the noted filings, coordinating and synthesizing input from the required technical experts. Must be detail-oriented with good oral and written communication skills. Must be able to multi-task and to keep to the timelines established for the respective filings.
ESSENTIAL DUTIES AND RESPONSIBILIITIES:
1. Responsible for generating the technical content for the Chemistry, Manufacturing and Controls (CMC) documentation required for investigation new drug applications and their respective amendments as well as initial marketing applications along with the required supplements and amendments.
2. Using standardized templates prepare the respective technical sections for a given regulatory filing.
3. Coordinate the completion of the CMC templates with the Regulatory Affairs (CMC) Organization for those filings assigned.
4. Summarize technical reports and documents to meet the needs of a given template section.
5. Maintain a working knowledge of the project plans for those projects where you are a contributor to ensure that the CMC sections are delivered on time. As required, lead the efforts for a given filing. This will required a project plan to be maintained based on the deliverables established by the product project teams and the filing schedule established by the Regulatory (CMC) Affairs organization.
6. As required serve as a member of multi-disciplinary teams organized to ensure project timelines are met and clinical and commercial supplies are available when needed.
7. Assist manager with the mentoring of the teams less experienced members.
8. Assist manager with the preparation of an optimized work flow for document creation, review and completion.
Experience and Skills:
ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE:
1. A minimum of 10 years Biopharmaceutical or Pharmaceutical Industry experience which should include a minimum of 3 years of regulatory including the handling/authoring of regulatory documentation or related experience. Credit given toward years of industry experience to those with advanced degrees.
2. A working knowledge of global regulatory requirements.
3. A working technical knowledge of the biopharmaceutical manufacturing process preferably in the area of antibody manufacturing. Expertises in a technical discipline a plus.
4. BS//BA degree in Biochemistry, Chemistry, Microbiology, Pharmaceutics, Chemical Engineering or related field. An advanced degree a plus.
5. Working knowledge of cGMPs as they apply to the Regulatory environment.
6. Excellent communication skills, both oral and written with demonstrated skills in the preparation of complex regulatory filings.
Additional Information:
Job Level: Management
Number of Openings: 1
Years of Experience:
Level of Education: BA/BS
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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