ASSOCIATE – REGULATORY OPERATIONS – ENTRY LEVEL

SciLucent, Inc., an employee-owned (ESOP) Northern Virginia-based scientific consulting firm provides innovative solutions in all aspects of drug development. We are committed to helping our clients navigate the complexities of the pharmaceutical industry to achieve their goals. Our scientific consulting team is expanding, and we are seeking an enthusiastic, adaptable, self-motivated individual with excellent oral and written English communication skills to join our team. 

Position Summary:
The Regulatory Operations Associate will be preparing and publishing regulatory submissions for regulatory agencies (i.e., FDA).  The daily 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.
• Verifies referencing 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 works with regulatory document authors to achieve resolution and compliance with specifications.
• Manages time effectively to prioritize competing tasks, meet multiple submission timelines, and support efficient project execution.

Minimum requirements include a Bachelor’s degree in a relevant discipline, strong writing skills, excellent, attention to detail, computer, and presentation skills, ability to balance multiple tasks to meet priorities and timelines, and demonstrated experience working in a team environment. We desire folks that have inherent curiosity and internal drive to provide excellent service to clients. 

Employees work remote from their home office which must be located in the United States.  Our most valuable resource is our people. We hire intelligent, creative, passionate professionals with a strong desire to learn. At our core – collaboration, camaraderie, growth, and collective hard work without egos. Our culture is one that encourages, supports, and celebrates our colleagues! We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.  Additionally, we offer the following benefits: medical, dental, vision, FSAs, HSA, EAP, Life insurance, disability insurance, 401K with company contribution, ESOP, Holidays, and PTO.  The annual base salary for this position ranges from $50,000 - $80,000 depending on qualifications and experience.  Any offered salary is based on internal equity, internal salary ranges, market data/ranges, applicant’s skills and prior relevant experience, certain degrees, and certifications.

Please send a resume and cover letter to career@scilucent.com.  Applications without cover letters will not be reviewed.

SciLucent is an equal opportunity employer.  We thank all applicants for their efforts in applying for our open position; while all applicants will be considered, only candidates selected for interviews will be contacted.