DataRevive USA LLC is a regulatory consulting company helping pharmaceutical and biotech companies with their regulatory filing of US IND, BLA, and NDA during drug development. We specialize in both small molecule and biologic product regulatory affairs with specific expertise in CMC (chemistry, manufacturing, controls), nonclinical, clinical pharmacology and clinical areas. For more information, go to www.datarevive.com.
Essential Duties & Responsibilities
- Provide subject matter expertise to clinical study and project development teams in the design, conduct, and reporting of clinical trials in both early and late development stages
- Write phase 1-3 clinical protocols, orphan drug designations and pediatric study plans
- Collaborate with the Non-Clinical team to determine FIM doses, biomarkers, and pharmacogenomics plans
- Collaborate with preclinical PK/PD to translate preclinical data to support human PK and efficacious dose projections; provide scientific justification for optimal human starting dose and dose escalation schemes for FIH studies
- Contribute to regulatory strategy to regulatory documents including writing Investigator Brochures, IND’s, briefing books, BLA and MAA submissions, post-approval filings, and responses to health authority questions
- Assist clinical team with additional assigned projects
- M.S. or PhD in Pharmaceutics, Biology, Pharmacology
- 4 years of relevant work experience
- Experience writing NDA/BLA modules 2 and 5
- Ability to analyze and critically assess PK/PD data
- Demonstrated ability to work in a collaborative, cross-functional team environment
- Excellent verbal and written communication skills
- Self-motivated, able to work independently with minimum supervision
- Prolonged periods of sitting at a desk and working on a computer.
What we offer you
You’ll be a member of a phenomenal group of business professionals that have an innovative and team approach to success, based out of Rockville, MD. We guarantee that you will have tremendous learning opportunities and will be actively encouraged to creatively contribute. Our benefits are comprehensive and include medical, dental, vision, 401(k) matching, and generous flexible vacation and sick time allowances.
DataRevive USA LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Validant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.