Join the SciLucent Team
SciLucent encourages scientific and regulatory professionals to contact us regarding employment opportunities. If you do not see any positions listed below, we currently are not actively recruiting for any positions, however, we always welcome inquiries, and resumes submitted will be considered for upcoming open positions.
ASSOCIATE – REGULATORY OPERATIONS – ENTRY LEVEL
SciLucent, Inc. is a Northern Virginia-based scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of FDA-regulated products. We are expanding our scientific consulting team with enthusiastic, adaptable, self-motivated individuals with excellent oral and written English communication skills and a keen eye for details for this entry-level position.
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 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 works with regulatory document authors to achieve resolution and compliance with specifications.
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.
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, a competitive salary, flexible benefits, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.
Please send a resume, cover letter, and writing sample to email@example.com. Applications without cover letters will not be reviewed.
SciLucent is an equal opportunity employer. We thank all applicants for their interest and effort in applying for our open position; while all applicants will be considered, only candidates selected for interviews will be contacted.
Send a cover letter and CV or resume
SciLucent offers a congenial work environment, the opportunity to work with knowledgeable consultants in multidisciplinary teams and learn the business of healthcare product development, a competitive salary, flexible benefits, profit sharing, and a tremendous opportunity for growth.
SciLucent is committed to equal employment opportunity as a sound business practice. Employment practices will not be influenced or affected by an applicant’s or employee’s race, color, religion, sex, national origin, age, disability, sexual orientation, marital status, or any characteristic protected by law. Please see the two links below for important notices for job applicants and employees:
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
Equal Employment Opportunity Commission: https://www.eeoc.gov/employers/upload/poster_screen_reader_optimized.pdf
For other information regarding employment:
585 Grove Street, Suite 300
Herndon, VA 20170