Regulatory Operations Contractor

Location(Boston): Can be fully remote; must work EST hours - (if local maybe come in monthly for C&C days)

Contract Term: Contract through EOY with possible extension

• Should have strong Word, PDF, Adobe skills – going through documentation, cleaning it up, getting approvals, submissions, sending out to Reg
• Document publishing is key, submission publishing with document publishing is even better
• Supported preparation of NDA and created project plans for NDA modules
• Extensive bookmarking and hyperlinking, taking all the submission documents and hyperlinking all the supporting study data and reports.

Position Summary:

Reporting to the Senior Director, Regulatory Operations, the Regulatory Operations Contractor will assist with the development and implementation of systems and procedures used to support regulatory submission activities including eCTD production, document publishing, and document management. This position will also be responsible for participating in day-to-day Regulatory Operations activities in support of the company’s goals.

Responsibilities:

·       Represent Regulatory Operations by participating on assigned teams to support submission scheduling and ensure coordination of system development activities;

·       Coordinate and participate in the production of electronic regulatory submissions;

·       Support and conduct cross functional training on submission standards, procedures, and systems as required;

·       Support compliance with worldwide submission regulations and guidelines.

Qualifications:

·       Experience compiling electronic submissions and in electronic document publishing;

·       Experience compiling IND, NDA/BLA, and CTD submissions;

·       Understanding of eCTD submission requirements;

·       Excellent communication and interpersonal skills;

·       Demonstrated ability to work well with cross functional teams;

·       Demonstrated ability to manage priorities and work under tight deadlines;

·       Demonstrated skills managing timelines and organizing supporting resources;

·       2+ years of pharmaceutical industry experience preferred;

·       2+ years of experience compiling electronic submissions preferred;

·       Proficient with Microsoft Office products and Adobe Acrobat.