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.
REGULATORY OPERATIONS ASSOCIATE
(Job Posting Number: 20171116 )
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 English communication skills.
The primary responsibility of the Regulatory Operations Associate is to prepare and publish electronic regulatory submissions, taking submission components from content-final electronic Common Technical Document (eCTD) files to published output. The Regulatory Operations Associate will ensure documents use formats and styles compliant with regulatory and company standards and will work with authors, project managers, and Regulatory Operations staff to ensure quality standards and required timelines are met.
- Process, publish, and review electronic regulatory submissions in eCTD format on a daily basis.
- Perform quality control review of technical aspects of regulatory submissions and critical review of submission components to ensure technical completeness of submissions.
- Interact with publishing software vendors and regulatory electronic submissions support groups.
- Keep current with FDA expectations for the content and format of regulatory documentation.
- Assist with Regulatory Operations administrative activities.
- Assist with production of paper submissions.
- Provide support to staff in the practice areas of clinical, nonclinical, regulatory, quality and drug development.
Minimum requirements include:
- Bachelor of Science/Arts Degree
- 2+ years combined pharmaceutical and Regulatory Operations experience
- Demonstrated knowledge and experience with writing, reviewing, preparing, and publishing of submissions in eCTD format
- Demonstrated knowledge of industry publishing requirements, guidelines, and trends, both paper and electronic
- Demonstrated knowledge of drug development
- Technical knowledge of electronic publishing systems and software, experience with GlobalSubmit preferred
- Proficiency with MS Office Suite and Adobe Acrobat software
- Ability to balance multiple tasks to meet priorities and timelines and follow projects through to completion
- Strong attention to detail with the ability to proofread and check documents for accuracy and inconsistencies
- Ability to work independently or in teams
- Excellent interpersonal, organizational, and written and oral communication skills
- Willingness to work outside of normal business hours, as necessary
We offer a congenial work environment, opportunities for growth in project management with knowledgeable consultants in multidisciplinary teams, a competitive salary, flexible benefits, and profit sharing.
Please send a resume and cover letter to firstname.lastname@example.org. Include the Job Posting Number on all documents submitted. Applications without cover letters will not be reviewed.
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