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Regulatory cmc project manager

Company Name:
The Judge Group
Job ID: 412621
Job Title: REGULATORY CMC PROJECT MANAGER
Job Type: Contract
Company: JUDGE GROUP
Location: Hopewell, NJ
Contact E-mail:
Salary: Open
Description: Our client, a large pharmaceutical company, is currently seeking a REGULATORY CMC PROJECT MANAGER.
Description:
- The candidate will be responsible for preparing CMC documents for global regulatory submissions in alignment with company objectives.
- The individual will have responsibility for executing a global regulatory submission strategy for manufacturing changes, annual reports and coordinate responses to health authority questions within agreed upon timelines.
- This position requires strong interaction with Global Manufacturing and Supply personnel at manufacturing sites and other key partners both internal and external to the company.
- Candidates should have the ability to manage multiple projects independently.
Requirements:
- Minimum BS degree in Chemistry/Biochemistry, Chemical Engineering, Pharmacy, Biology or related science.
- Minimum of 2-5 years of experience in the Pharmaceutical Industry with CMC submission experience.
- Pharmaceutical background with knowledge of CMC regulations and guidances is required.
- The candidate will have demonstrated ability to be a strong team member with the ability to drive projects to completion on time while providing innovative new solutions to changing deliverables.
- This position requires good organizational, communication, electronic systems and project management skills.-PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, and good understanding of requirements for regulatory submission documents.
- Demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals
- Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities
- Working knowledge of a document management system and basic knowledge of document publishing process
Duties:
1. Coordinate and author regulatory documents (e.g. phase I/II clinical study reports, Investigatoras Brochure) ensuring the coordination and integration of the scientific, medical and regulatory input from development team members.
2. When assigned as Lead Writer, ability to lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions.
3. Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas or multiple projects.
4. Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
5. Lead or co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells.
6. Able to collaborate with project team to respond to health authority questions, requests, etc.
7. Provide departmental management with adequate information to help assess resource needs.

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