Join the SciLucent Team
SciLucent encourages scientific and regulatory professionals to contact us regarding employment opportunities. Click on the titles below to view descriptions for each current position. Resumes will be considered for both current and upcoming positions.
Senior Scientific/Regulatory Affairs Professional
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 a senior, experienced scientific professional with strong regulatory skills to join our team of experienced professional consultants. We are looking for an enthusiastic, adaptable, self-motivated individual with excellent communication skills and demonstrated leadership ability for this position.
The responsibilities of the position include:
- Provide scientific and regulatory strategic support to colleagues and clients;
- Maintain current knowledge of US and international regulations and guidelines;
- Prepare and manage the preparation regulatory submissions to support the clinical testing and approval of pharmaceuticals, biologics, medical devices, and combination products;
- Develop and manage overall regulatory project timelines;
- Work with regulatory operations team to submit regulatory documents;
- Successfully manage regulatory authority interactions;
- Supervise and guide cross-functional project team professionals and support personnel.
The ideal candidate will have the following:
- An advanced degree in a relevant scientific discipline;
- At least 10 years’ experience in early stage healthcare product development with submission project management experience;
- Demonstrated ability to write and review scientific and regulatory documents in CTD and eCTD format;
- Demonstrated organizational and analytical skills;
- Proficiency in Microsoft Word, Excel, and Adobe Acrobat;
- Excellent knowledge of US and EU industry standards, regulations, and guidances;
- Strong communication and interpersonal skills;
- Demonstrated ability to manage multiple competing projects;
- Attentive to detail.
This is a full-time position in our Herndon, Virginia office.
Senior Regulatory Toxicology Consultant
SciLucent, LLC is seeking an experienced and seasoned Regulatory Toxicologist to join our multidisciplinary consulting team. The individual will work within the Nonclinical Safety & Development group and provide support to project teams and clients to develop and execute strategic and integrated nonclinical development programs for drugs, biologics, devices, and combination products in multiple therapeutic areas. The successful applicant will be able to work in a team environment and provide expert scientific and regulatory services while requiring minimal supervision for primary job functions and responsibilities.
- MS degree (Ph.D. preferred) in toxicology or a related and relevant scientific field
- 10 or more years experience working in nonclinical development, toxicology, and/or veterinary medicine in the pharmaceutical, biotechnology, and/or contract service industries
- Prior experience and knowledge in working with Contract Research Organizations (CRO)
- Must possess current knowledge and expertise in regulated drug development processes
- Track record of successfully authoring quality nonclinical regulatory documents
- Knowledgeable in regulatory guidance documents, precedents and GLP regulations
- Excellent communication skills and ability to effectively address scientific and regulatory questions under pressure
- Strong sense of teamwork and demonstrated experience working with project teams, clients and regulatory personnel
- Must be detail-oriented, with an ability to think critically and innovatively
- Must have a client service minded attitude and be able to travel
Essential Duties and Responsibilities:
The candidate will devise and execute integrated nonclinical development strategies to support the development activities of drugs, biologics, devices, and combination products. Job responsibilities include:
- Design and guide integrated national and international nonclinical drug development strategies
- Provide oversight and management of program outsourcing activities
- Review, analyze, and interpret scientific data, and effectively communicate data interpretation to project teams, clients, and regulatory agencies
- Author and/or critically review nonclinical submission packages for scientific content and quality
- Act as our nonclinical representative for Agency interactions and meetings
- Conduct scientific assessments (e.g., gap analysis, safety assessments)
SciLucent, LLC seeks an enthusiastic, adaptable, self-motivated individual with excellent oral and written English communication skills for this entry-level position.
- Preparation and compilation of regulatory documents;
- Quality review and publishing of regulatory submissions;
- Provide support to senior level consultants in the practice areas of clinical, nonclinical, regulatory, quality and drug development.
Minimum requirements include a Bachelor’s Degree (Master’s Degree preferred) in a relevant scientific discipline (e.g., toxicology, biology, chemistry, biochemistry, biomedical, etc.), strong attention to detail, excellent writing and computer skills, and demonstrated experience working in a team environment. Experience in the regulatory field preferred but not required.
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.
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.