SciLucent, LLC, a Northern Virginia-based scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals and medical devices, seeks an enthusiastic, adaptable, self-motivated individual with excellent oral and written communication skills and a keen eye for details for this entry-level position.
Position Summary The Regulatory Operations Associate will be reviewing, preparing, and publishing regulatory files for paper and electronic submission to regulatory agencies (i.e., FDA). The day to day responsibilities include formatting Microsoft Word files, converting files to PDFs, adding bookmarks and hyperlinks, with additional responsibilities outlined below.
Other Responsibilities include but are not limited to:
Publishes submissions by uploading documents to the proper location in the publishing software, adding external hyperlinks, and validates submission.
Conducts quality control (QC) reviews of PDF documents for correct bookmarking/hyperlinking and QC submissions for proper document placement, etc.
Communicates with regulatory agencies and publishing vendor regarding submissions
Develops and manages regulatory project specific timelines, and actively participates on project teams advising on submission preparation timelines, processes, and requirements
Verifies referencing of text against cited source documentation, including format and numbering of endnotes/citation numbers, and consistency of reference citation style
Maintains template and editorial style guide, and provides guidance on updates
Liaises with project managers, team leads, and content authors to ensure documents are compliant with authoring style guide, and work with regulatory document authors to achieve resolution and compliance with specifications.
Required Education and Skills:
Bachelors’ degree in a relevant field
Advanced computer skills in Adobe, MS Word, and other Office 365 programs
Strong organization skills and a meticulous eye for details
Excellent communication skills which includes written, verbal, and interpersonal (non-verbal communication, positive attitude, and listening)
Strong analytical and problem-solving skills
Flexibility to manage changing requirements and priorities
Works independently as well as in a team environment
Additional Salary Information: We offer a congenial work environment, the opportunity to work with knowledgeable consultants in multidisciplinary teams providing services in the business of healthcare product development, a competitive salary, flexible benefits, profit sharing, and a great opportunity for growth.
Internal Number: REGOP2019
About SciLucent LLC
SciLucent, LLC is a Northern Virginia-based scientific and regulatory consulting firm providing services to manufacturers, distributors, and marketers of healthcare products. We offer a congenial work environment, the opportunity to work with knowledgeable regulatory consultants, a competitive salary, flexible benefits, profit sharing, and a tremendous opportunity for growth.
BACK TO TOP
Ready for SEMDA's unique resources and networking opportunities to grow your business?