CLINICAL DEVELOPMENT & REGULATORY AFFAIRS ASSOCIATE (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. This role focuses on providing support for our Clinical Development and Regulatory Affairs functional area. The ideal candidate will have a passion for the pharmaceutical industry and a desire to learn and grow within the field.
Responsibilities of the position include:
• Assist with authoring clinical and regulatory documents including clinical protocols, Investigator Brochures, Clinical Study Reports, and Annual Reports.
• Assist with authoring clinical sections of regulatory submissions.
• Interface with team members and clients to ensure timely completion of project assignments.
• Coordinate and manage regulatory submissions.
• Acquire and apply knowledge of regulatory submission types and associated requirements.
• Perform data and editorial quality review of clinical and regulatory documents for accuracy and completeness.
• Prepare submission-ready PDFs, generate published outputs, and perform quality control review of submissions.
• Collaborate with cross-functional teams to ensure Company standards are met.
• Provide support to colleagues in the other SciLucent functional areas as needed.
The ideal candidate will have the following:
• Bachelor's degree, in a relevant scientific discipline (e.g., biology, chemistry, biochemistry, clinical research, etc.) or equivalent relevant scientific/regulatory/quality experience, is required.
• Strong attention to detail and organizational skills.
• Strong computer skills (e.g., Microsoft Word, Excel, PowerPoint, etc.) and ability to acquire knowledge of job-specific software.
• Ability to balance multiple tasks and timelines.
• Ability to work independently and within a group setting and to interact effectively with different functional areas.
• Excellent communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
• Possess an inherent curiosity and internal drive to provide excellent service to clients.
• Experience in drug development, biotech, quality, and regulatory affairs is a plus but not required.
• Experience with AI tools and software is a plus but not required.
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 [email address]. 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.
Remote
Skills:
Artificial Intelligence (AI), Biochemistry, Biology, Biotech and Pharmaceutical, Brochures, Chemistry, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Support, Clinical Trial, Communication Skills, Computer Skills, Consulting, Cross-Functional, Customer Support/Service, Detail Oriented, Drug Development, English Language, Healthcare, Interpersonal Skills, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Multitasking, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Quality Control, Regulations, Regulatory Submissions, Time Management, Writing Skills
About the Company:
SciLucent LLC
Responsibilities of the position include:
• Assist with authoring clinical and regulatory documents including clinical protocols, Investigator Brochures, Clinical Study Reports, and Annual Reports.
• Assist with authoring clinical sections of regulatory submissions.
• Interface with team members and clients to ensure timely completion of project assignments.
• Coordinate and manage regulatory submissions.
• Acquire and apply knowledge of regulatory submission types and associated requirements.
• Perform data and editorial quality review of clinical and regulatory documents for accuracy and completeness.
• Prepare submission-ready PDFs, generate published outputs, and perform quality control review of submissions.
• Collaborate with cross-functional teams to ensure Company standards are met.
• Provide support to colleagues in the other SciLucent functional areas as needed.
The ideal candidate will have the following:
• Bachelor's degree, in a relevant scientific discipline (e.g., biology, chemistry, biochemistry, clinical research, etc.) or equivalent relevant scientific/regulatory/quality experience, is required.
• Strong attention to detail and organizational skills.
• Strong computer skills (e.g., Microsoft Word, Excel, PowerPoint, etc.) and ability to acquire knowledge of job-specific software.
• Ability to balance multiple tasks and timelines.
• Ability to work independently and within a group setting and to interact effectively with different functional areas.
• Excellent communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
• Possess an inherent curiosity and internal drive to provide excellent service to clients.
• Experience in drug development, biotech, quality, and regulatory affairs is a plus but not required.
• Experience with AI tools and software is a plus but not required.
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 [email address]. 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.
Remote
Skills:
Artificial Intelligence (AI), Biochemistry, Biology, Biotech and Pharmaceutical, Brochures, Chemistry, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Support, Clinical Trial, Communication Skills, Computer Skills, Consulting, Cross-Functional, Customer Support/Service, Detail Oriented, Drug Development, English Language, Healthcare, Interpersonal Skills, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Multitasking, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Quality Control, Regulations, Regulatory Submissions, Time Management, Writing Skills
About the Company:
SciLucent LLC