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Assoc Director-Mfg Tech CMC Reg Support(00880254) Location New Jersey - Branchburg Education Required... CMC documents. 4. Coordinate the development of CMC......
For your reference, we have included the original job posting below.
Assoc Director-Mfg Tech CMC Reg Support(00880254)
Job Number:
36549153
Company Name:
ImClone Systems
Job Location:
Branchburg, NJ US
Job Category:
Insurance
Assoc Director-Mfg Tech CMC Reg Support(00880254)
Assoc Director-Mfg Tech CMC Reg Support(00880254)
Location New Jersey - Branchburg
Education Required Bachelors
Job ID 50428505 Years of Experience Not Indicated
Functional Area Job Type Experienced
Job Description General Summary:
The individual will be part of a team that will provide support to the Regulatory Affairs (CMC) Organization. This team's primary responsibility will be to prepare the technical content for the Chemistry, Manufacturing and Controls (CMC) sections of investigational drug applications (INDs, CTAs), initial marketing applications and required amendments. Additional responsibilities include assisting the RA (CMC) group with the compilation of responses to health authority requests. The individual will interact with subject matter experts from various departments and coordinate information exchange during the synthesis of documents. The individual will represent this group on multi-disciplinary project teams. The individual must be detail-oriented and have excellent oral and written communication skills. Must be able to multi-task and adhere to the established project timelines.
Primary Responsibilities:
1. Responsible for generating the technical content for the Chemistry, Manufacturing and Controls (CMC) documentation required for investigational new drug applications and their initial marketing applications, along with relevant supplements, amendments and health authority responses. 2. Work collaboratively with the Biopharmaceutical Manufacturing and Development technical experts and the Regulatory Affairs CMC organization to prepare regulatory filings. 3. Extract and summarize information from technical documents for incorporation into CMC documents. 4. Coordinate the development of CMC filing related document templates with the Regulatory Affairs (CMC) Organization 5. Offer guidance and feedback during the preparation of project plans for each molecule to ensure CMC sections are delivered on time. The project plans will be based on the deliverables established by the product core teams and the filing schedule established by the Regulatory Affairs (CMC) organization. 6. Participate as a member of multi-disciplinary teams to ensure project timelines impacting the availability of clinical and commercial supplies are met. 7. Develop and supervise direct reports. 8. Work with colleagues towards continual improvement of the work flow process: document creation, document review and document completion. 9. When required, assist with development and maintenance of the department budget.
Required Knowledge, Skills & Education:
1. Responsible for generating the technical content for the Chemistry, Manufacturing and Controls (CMC) documentation required for investigational new drug applications and their initial marketing applications, along with relevant supplements, amendments and health authority responses. 2. Work collaboratively with the Biopharmaceutical Manufacturing and Development technical experts and the Regulatory Affairs CMC organization to prepare regulatory filings. 3. Extract and summarize information from technical documents for incorporation into CMC documents. 4. Coordinate the development of CMC filing related document templates with the Regulatory Affairs (CMC) Organization 5. Offer guidance and feedback during the preparation of project plans for each molecule to ensure CMC sections are delivered on time. The project plans will be based on the deliverables established by the product core teams and the filing schedule established by the Regulatory Affairs (CMC) organization. 6. Participate as a member of multi-disciplinary teams to ensure project timelines impacting the availability of clinical and commercial supplies are met. 7. Develop and supervise direct reports. 8. Work with colleagues towards continual improvement of the work flow process: document creation, document review and document completion. 9. When required, assist with development and maintenance of the department budget.
