• Lancesoft
  • $121,965.00 -156,260.00/year*
  • Cambridge , MA
  • Education - Excluding Post Secondary
  • Full-Time
  • 101 Auburn St

On-Site TBOS
6 month duration June through Dec

General Summary
Provides support and expertise in the development and maintenance of regulatory affairs systems.
There are 2 key areas in which individuals can contribute:
End User Support and Business Analysis focus on user requirements, business processes, training issue resolution and systems governance
Project Management - focus on the delivery of systems development / maintenance activities
There are also responsibilities which apply to both areas.
Primary Responsibilities
Develops and maintains the systems and tools, and supports the users across the portfolio of information systems required to meet the needs of the global regulatory affairs organization.. The portfolio includes electronic document management (EDMS), publishing, viewing, validation, compilation, labeling, reg CMC and regulatory information management systems.
Governs the systems in production by monitoring user challenges and issues. Prioritizes and manages associated system change requests.
Participates in system improvement projects.
Supports validation activities to ensure that quality solutions are delivered to the end user to meet set business requirements as well as conform to company technology principles, architecture, and strategies.
Stays abreast of regulatory and industry changes that may impact global regulatory operations. Interprets regulatory guidance as related to systems and makes plans to adapt company systems and processes as appropriate.
Level-Specific Descriptors

Sr Regulatory Systems Specialist
Contractor with a focus on Reg. Information Management Tracking Systems

Level-Specific Responsibilities Assists users with the resolution of problems associated with regulatory affairs systems.
Coordinates group training with end users.
Assists with developing and maintaining support and training materials / tools for regulatory affairs system applications.
Oversees the end user access controls for regulatory systems. Performs annual recertification.
Analyses trends in end user issues and proposes solutions for resolution.
Contributes to system governance activities for regulatory systems, including the impact analysis of change requests.
Performs guided analysis of existing regulatory affairs systems to identify opportunities for improvements or new solutions satisfaction.
Participates in design sessions and inputs on the solution for internal and external clients.
Follows trends in regulatory environment and technology.
Knowledge, Skills and Abilities Good knowledge of regulatory affairs principles, processes and regulations
Working knowledge of the company's information technology principles and architecture
Good knowledge of business analysis principles.
Excellent listening, written and verbal communication skills
Strong time management skills
Excellent ability to determine unstated user needs through application of functional knowledge
Ability to quickly learn new applications, processes and procedures of varying complexity
Problem Solving Problems are differing but related. Solutions are not readily apparent. Undertakes analysis and investigation to identify and define problems. Anticipates future issues. Work is done independently, reviewed at critical points.
Interaction Adapts style and uses persuasion in delivering messages. Issues may be complex, audience perspectives may be divergent, and information may be non-routine in nature.
Impact Establishes approach and leads resources to achieve operational and strategic plans. Impact is focused on medium-term goals.
Typical Min. Education* Bachelor's degree in relevant field of study.
Typical Minimum Experience* 3 years of relevant experience
* Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities or requirements.
Associated topics: admission, clinician, counselor, guidance, healthcare, nurse, registration, school clerk, school clerk assistant, school counselor

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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