Sarepta Therapeutics is looking for an energetic and resourceful, Senior/R&D Systems Analyst who will be responsible for the portfolio of current and new applications used by Regulatory, Quality, Clinical, Data Management, etc. Under general direction, this individual administrates, supports, and maintains applications software and systems. This includes performing administrative and management tasks to maintain application operation, installing new systems, developing reports, supporting ancillary software, and maintaining system compliance, security, and performance. This position will serve as an interface with system users, and vendor contacts, and will assist with GxP Compliance procedures.
Primary Responsibilities Include:
* Responsible for supporting and administrating the various R&D systems that Sarepta has.
* Works on technical Validation activities of R&D systems including change control on GxP systems
* Supports the vendor relationship for R&D systems, ensuring that our system issues are communicated
* Interfaces with business units to understand their business processes, and system related requirements
* Communicates business needs/system needs with other IT Applications Staff
* Perform other duties and responsibilities, as assigned
Education and Skills Requirements:
* 5+ years of experience in the IT role working with R&D systems in a biotech/pharmaceutical company
* Experience with validated GxP environments, including Implementation, documentation, and Change Management is a must
* Good Project Management skills and attention to detail/good documentation skills
* Ability to juggle multiple large projects/priorities
* Ability to communicate effectively, translating tech terms to business terms and tech to business terms
* A high level understanding of regulations surrounding GxP systems (such as 21CFR part 11)
* Experience architecting (GxP, Non GxP, Cloud and Non Cloud) is a plus
* Exposure to either Clinical, Regulatory, BioStats, and Quality systems is a plus
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
About Sarepta Therapeutics
Sarepta Therapeutics is a biopharmaceutical company focused on developing innovative RNA-targeted therapeutics.