Job Title: Submissions Manager

Duration: long-term contract.

Location: 100% Remote position.

Client: Moderna

This position would require a unique schedule:

Time zone-EST preference

Remote role

Hours:

Monday 1-9pm EST

Tuesday off

Wednesday off

Thursday 1-9pm EST

Friday 1-9pm EST

Saturday-9-5pm EST

Sunday-9-5pm EST

Job Description:

Manage the development and maintenance of a submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing and QC.

As a global submissions’ expert, ensure the project team has awareness and knowledge of esubmissions (eCTD, NeeS, etc.) and life cycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.

Effectively communicate project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed.

Provide operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (IND, NDA, MAA, etc.), updates, amendments, and variations to global regulatory agencies.

Manage activities of the publishing vendors in preparation of high-quality submission packages and their timely delivery to health agencies.

Maintain technical expertise of regulatory requirements and ensures alignment with company processes and client requirements.

Act as a subject matter expert for document management system and support Veeva RIM activities as needed

Compile regulatory submissions. Coordinate distribution of submissions to all concerned parties (HA, CRO) within agreed upon timeframes. Manage submission and product lifecycle information.

Format documents as needed to ensure they are submission ready.

Thanks & Regards,

Karthik Siddi | Senior Engineering Recruiter
D: 908-356-6657 | (karthik)@neotechusa.com
One Cragwood Rd | South Plainfield, NJ 07080
eFax: 888-828-9871| www.neotechusa.com

Job Types: Full-time, Contract

Salary: $50.00 - $55.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Weekend availability

Work Location: Remote

Please Note :
clarksqn.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, clarksqn.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.