Submissions Specialist (pharma)

Pharma Submissions Specialist

Job Description:
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.

Location: Remote (US only)
Hours: Second shift preferred (EST)
Duration: 5+ weeks (strong possibility for extension)
Rate: $35-43/hr

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.

Requirements:
– 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 FUSE
– Strong attention to detail with excellent organizational skills.
– Ability to work effectively in cross-functional teams under tight deadlines