Technology and Content Integration Lead
Looking for a Leader with problem-solving skills and extensive experience with managing and executing ETL and data cleansing/classification and migration projects. You are proficient at presenting in front of clients with your excellent communication skills. You have the ability to perform scoping analysis with minimal direction to provide high level timeline and activities for new business development efforts.
You are energetic and a true 'go-getter.' You are able to interpret business speak and turn it into IT speak and vice versa, bridging the gap between business requirements and our team's technical implementation of those requirements. You have led or are interested in leading offshore/onshore development and execution efforts across a diverse team of resources. You have an aptitude for putting together dashboards and trackers and managing the assignment of activities to a team of resources so that they may be tracked and measured to optimize outcomes to our clients.
With your thorough understanding of relational databases, SharePoint and Excel you take an analytical and rational approach to problems, and you have an uncanny ability to be open minded and creative in terms of developing a new solution or to improve on existing ones. Your strengths extend to identifying patterns and insights on large unstructured data sets where none are obvious to a layman.
You have a broad understanding of the regulatory landscape, knowledge of key high-level processes such as US/EU Submissions. This knowledge extends to content included in eCTD and non-eCTD submission types and may even extend into Clinical, Quality and Safety areas of R&D. Experience in 21 CFR Part 11 systems and relevant EDMS and other functional information management systems is needed.
Your future duties and responsibilities
• Collect business requirements for the identification, classification and migration of R&D content from electronic filing systems and tools to regulated content and information management systems
• Lead and/or coordinate business and technical activities, on, and offshore across a diverse team
• Share and communicate methodologies, plans and status on activities with client leads and CGI team members
• Identify opportunities for digital innovation, robotic process automation, ML, NLP, AI and more
• Identify and qualify new business opportunities and work with account and internal technology teams to efficiently solve customer challenges
Required qualifications to be successful in this role
• 10+ years relevant experience working in related Health Care, Life Sciences industry
• 10+ years relevant experience performing analysis and critical thinking for EDMS and/or ETL projects
• 10+ years working with Excel with demonstrated experience filtering, analyzing data to make recommendations on actions, and applying macros, functions, and pivot tables
• 10+ years experience with SDLC activities working in a regulated environment
• 7+ years experience working on data migration projects
• 7+ years experience performing data analysis
• 7+ years experience as technical lead on projects
• 5+ years relevant experience in Veeva, Aplexor, Documentum, FirstDocs, etc.
• 5+ years implementing and working with Pharmaceutical Regulatory systems
• 5+ years business process analysis, swim lanes, data flows
• Understanding of the regulatory landscape in regards to submissions such as eCTD, non-eCTD and NeeS
• Understanding of the regulatory landscape in regards to US and EU submission processes
• Programming background with the ability to document/outline logical data processes.
• Proven experience working with a cross-functional US / India Team on projects
• Strong focus on quality; high attention to detail demonstrated through proofing, follow through and scheduling
• Thrives in a dynamic work environment where they are adept at balancing priorities for efficient workflow, particularly under tight deadlines
• Ability to work in a team-oriented setting, to prioritize work, and to follow through on assignments with minimal direction as well as back-up colleagues as needed
• Self-motivated and striving for continuous self-improvement; actively engaging in self-directed learning related to professional development.
• Bachelor's Degree from an accredited college/university and 10+ years relevant experience
• Creative thinker with ability to seek innovative solutions to complex technical/business problems
• A team player that is able to put the project or team success before their own, while also developing other members of the team in the process
Skill Set Years of Experience Proficiency Level
Health Care, Life Sciences industry 10
EDMS, ETL and/or data and content 7-10
SDLC in a regulated environment 10
Technical Project management/Leadership 7
Veeva, Aplexor, Documentum, FirstDocs and/or other regulated R&D systems usage 5-7
Business Process Analysis and Mapping 5-7
Advanced Excel (Pivot tables, macros) 10
DESIRED QUALIFICATIONS/NON-ESSENTIAL SKILLS REQUIRED
• SAFe/ Agile knowledge
• Regulatory business experience and knowledge of the product approval lifecycle for product development to post marketing activities, including but not limited to Regulatory Submission, Authoring, Labeling, Publishing et al.
• SharePoint experience
• 5+ years programing experience in Java and/or C#
• ETL tool experience, such as talend, fme migration center
• Power Shell 2+ years
• Lean and Lean Six Sigma knowledge
• 5-8 Years .NET development experience
• 5-8 Years java development experience
• 2-5 Years experience in virtual desktop computing
Skill Set Years of Experience Proficiency Level
Java, .NET and/or C# Programming 5-7
Virtual desktop computing 5-8
Minimum Education Required: B.S Computer Science, Natural Sciences, Engineering or equivalent
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- RPA Development