24 Seven Talent | Pharma Submissions Specialist | new york city, ny
4 days ago
Role Overview: We are currently seeking a highly skilled and detail-oriented Pharma Submissions Specialist to join our team on a temporary basis. As a Submission Specialist, you will be responsible for managing the submission process for pharmaceutical products, ensuring compliance with regulatory requirements and timely submissions to health authorities.
Pharma Submissions Specialist Responsibilities:
- Collaborate with cross-functional teams, including Regulatory Affairs, Clinical Operations, Quality Assurance, and Medical Writing to gather necessary documentation for submissions.
- Ensure all submitted documents meet regulatory standards and guidelines.
- Prepare submission packages according to specific health authority requirements.
- Conduct quality checks on submission documents for accuracy and completeness.
- Maintain up-to-date knowledge of relevant regulations and guidelines related to drug submissions.
- Keep track of submission timelines and ensure timely delivery of submissions.
- Assist in resolving any issues or queries related to submissions from health authorities.
Pharma Submissions Specialist Qualifications:
- Proven experience as a Submissions Specialist within the pharmaceutical industry.
- In-depth knowledge of FDA regulations pertaining to drug development and submissions is essential.
- Experience with Veeva or FUSE
- Strong attention to detail with excellent organizational skills.
- Ability to work effectively in cross-functional teams under tight deadlines
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new york city, United States 24 Seven Talent Full timeRole Overview: We are currently seeking a highly skilled and detail-oriented Pharma Submissions Specialist to join our team on a temporary basis. As a Submission Specialist, you will be responsible for managing the submission process for pharmaceutical products, ensuring compliance with regulatory requirements and timely submissions to health...
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