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, is looking to expand its regulatory affairs consultant team with an experienced scientific professional with strong interpersonal skills. We are looking for an enthusiastic, adaptable, self-motivated individual with excellent communication skills and demonstrated project management ability for this position.
Provide strategic support and guidance to clients to ensure that developmental activities are effective and that regulatory documentation is accurate and compliant with relevant regulations, guidelines, and industry standards
Compile, organize, and manage the production of clear and persuasive regulatory submissions for pharmaceuticals, biologics, and combination products
Draft and review all regulatory documents for scientific content, quality, and messaging
Develop and manage the implementation of scientific/regulatory strategies and associated project timelines
Effectively lead communications with clients, healthcare agencies, and project team
Act as an internal resource for colleagues on regulatory issues
Lead and guide cross-functional project team professionals
Participate in business development activities
Minimum of a Bachelor’s degree in a relevant scientific discipline (e.g., biology, biomedical engineering, etc.); advanced degree preferred
A minimum of 5 years’ experience as a scientific/regulatory professional and a demonstrated understanding and familiarity with pharmaceutical and biological development and registration
Demonstrated ability to write and review scientific and regulatory documents
Strong knowledge of US industry standards and applicable guidance documents
Skills and Capabilities
Strong project management, communication, and interpersonal skills
Ability to interpret scientific information
Ability to build and maintain client relationships
Familiarity with document preparation and publishing systems
Fluency in vocal and written English
This is a full-time position in our Herndon Virginia office, although remote employees may be considered. We offer a collegial work environment, the opportunity to work with knowledgeable consultants, a competitive salary, flexible benefits, retirement plan, generous paid time off plan, profit sharing, and a tremendous opportunity for growth. This position may require occasional travel. Please feel free to visit our website at www.scilucent.com. We look forward to receiving your resume and cover letter which you may send to us at email@example.com.
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.
Internal Number: 09122019
About SciLucent, LLC
SciLucent, LLC, located in Herndon, Virginia, provides regulatory, scientific, and management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, medical devices, combination products, and dietary supplement ingredients.
Since 1998 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Our areas of expertise include manufacturing & development, quality & compliance, nonclinical safety & development, clinical development, regulatory affairs, and regulatory operations.