ProClinical has a brilliant opportunity for a Data Analyst RIM to be based in Somerville, NJ. This job will be with one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors. The Data Analyst will perform comprehensive data analysis to aid in the development of an integrated cross-MD Regulatory information technology solution that will facilitate global tracking, business workflow, reporting and analysis of critical Regulatory information and work output, including product registration, health authority interaction, document/content management, communications, and business analytics. RIM will serve as the lifeblood to the regulatory lifecycle management of all products across multiple Med Devices business units globally.
- Rapidly gain an understanding of RIM vision for J&J Med Devices
- Take a complete inventory of all Regulatory information artifacts from specified J&J Med Devices Regulatory Affairs business units (and relevant non-Regulatory information sources)
- Support development of accelerated plan for data gathering and analysis phase; coordinate with RIM PM and RIM Business Requirements Team
- Execute data gathering plan
- Participate in business stakeholder workshops (as necessary) to standard, harmonize and align data model
- Actively participate in assessment of current state data domain including the source & steward of each data artifact, estimate of effort to harmonize and transform data, and recommendation for future information model to adequately support RIM
- Establish strong working relationships with key data stakeholders
- Identify critical gaps and/or impediments to effectively achieving goals
- Identify/escalate critical issues in a timely manner
- Provide necessary input to project dashboards/progress checks at regular intervals
Skills and Requirements:
- A minimum of a Bachelors degree or equivalent
- Minimum of 5 years relevant experience in a regulated industry
- Relevant data management experience / expertise
- Understanding of Regulatory business process, a plus
- Understanding of J&J enterprise systems environment a plus
- Ability to rapidly gather and process information from key business partners to understand the various Regulatory business function and supporting data artifacts, including sources of data, quality of data and understanding how data flows in/out of function
- Ability to understand cross-enterprise data flow and systems
- Working knowledge of accepted and emerging healthcare information standards
- Fosters excellent cross-functional communications and works effectively across team to achieve business objectives
- Excellent communication skills, ability to establish positive working relationships and gain trust of business partners
- Strong analytical and organizational skills with the ability to work across diverse business landscape
- Preferred experience working within health care regulatory environment such as medical devices, pharmaceuticals or consumer products
- Able to work collaboratively in a highly matrixed environment
- A strong results-orientation and sense of urgency whilst demonstrating proficiency and success in prioritizing and handling multiple tasks simultaneously
- Strategic thinking and ability to partner with internal stakeholders at multiple levels of the organization
- Ability to achieve results under demanding time constraints with expansive and changing priorities.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Goldberg on +1 267 538 1182 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.