Job Description :
Qualifications and Requirements:
3-5 years minimum experience in the Information Technology field.
3+ years of working in Bio-Tech/Bio-Pharmaceutical Industry supporting R&D as a business analyst.
Strong knowledge of processes and applications related to Clinical Operations, Medical Affairs, Clinical Data Management, Clinical Science, Biostatistics, and Drug Safety & Pharmacovigilance (e.g. CTMS, EDC, IRT, CRO data transfers, Oracle Argus, JReview, SAS, etc.
Knowledge of procedures and best practices related to FDA, EMA, GxP, CFR21 Part 11, Computer System Validation, Sunshine Act, HCP
Transparency Reporting, and other regulations governing drug development and commercialization.
Working knowledge of scripting and database query languages (SQL, Python, Unix, C, Java, etc. )
Experience with SOP authoring relative to R&D processes and applications.
Ability to articulate complex technical problems and business value to a wide business audience.
Excellent verbal and written communication skills.
Ability to organize and present ideas in a convincing and compelling manner.
Ability to troubleshoot issues and work independently with minimal direction.
Self-motivated with high degree of initiative and excellent follow-up skills, along with strong analytical and problem-solving skills.