EDETEK is building a comprehensive set of technologies to greatly improve management of processes and information in Pharmaceutical Clinical R&D. We are an industry leader offering a comprehensive clinical informatics platform CONFORM™ to numerous large and small biopharmaceutical companies and CROs.
We are looking for highly motivated and energetic clinical business technology professionals that have a passion for development of innovative industry leading processes and systems to improve and further differentiate our products.
Product Development Specialist will participate in design and development of requirements, testing and pre-sales activities of EDETEK’s CONFORM product line. Product Development Specialist will be contributing to one or more than one component of the CONFORM platform. Daily activities will include interactions with the product leadership team, software engineering, business analysis and quality departments.
Product Development Specialist must ensure that product functions operate in accordance with common CR&D business flows as well as industry regulations.
Product Development Specialist contributes to preparation of product demonstrations, meetings with customers and prospects and participation in industry forums.
The ideal candidate must possess knowledge of clinical patient and operational information flows. He/She must be skilled in industry-popular systems used in clinical trials.
- Assist in development of products in one or more than one clinical application areas
- Collaborate with Product Development Head, business analysts, internal subject matter experts, product engineering and QA to develop and test functional requirements for new applications
- Work with Software QA to ensure GxP and 21 CFR Part 11 compliance of the systems
- Clearly translate business requirements to the business analysts and engineers working on the project
- Guide business analysts to develop and document process and information flows
- Participate in RFP/RFI writing and bid defenses as a contributor
- Prepare and participate in industry forums and conferences
- Participate in solution implementation, if required
- Participate in pre-sales activities
EXPERIENCE AND EDUCATION REQUIRED
- 5+ years of hands-on experience in pharmaceutical clinical business and clinical information technology
- Good knowledge of CR&D processes and methods
- Demonstrated work experience as a business user and/or clinical business technologist in multiple clinical processes and applications (i.e. data collection, trial management and operations, data standardization, data transformation, data warehousing, analytics)
- Knowledge of clinical systems and vendors commonly used in the industry
- Understanding of quality and information privacy requirements applicable to clinical systems
- Outstanding communication and presentation abilities
- Ability to work with EDETEK teams in Europe
- BS/BA in computer science, engineering, mathematics, business, biology, life sciences or relevant field
DESIRED TECHNICAL SKILLS AND EXPERIENCE
- Knowledge of Clinical Data Standards (CDISC, HL7, etc.)
- Familiarity with Cloud Computing
- Knowledge of GxP, 21 CFR Part 11 and HIPAA requirements
- Understanding of software product development and SDLC
- Innovative business application mindset with great attention to detail
- Strong organizational and presentation skills
- Being able to work in the corporate office (Princeton, NJ) and/or home office remotely
- Availability in early hours to participate in scheduled global online meetings over the Internet/Skype
- Cross-functional and client interactions
- USA Residents or Citizens only
- Position reports to Product Development Head
- Complete Training Requirements per current Training Requirements List