As a Life Sciences Professional you will work closely with other Professional Service Consultants in the delivery of OpenText Life Sciences engagements (OpenText Documentum for Research and Development, OpenText Documentum for Quality and Manufacturing, OpenText Documentum for eTMF, OpenText Documentum Submission Store and View) and be responsible for scoping out new client projects.
You are great at :
Represent OpenText in a professional manner to customers, partners and other OpenText personnel at all times.
Educate prospects & customers on LSQM, LSRD, eTMF, SSV and LS Express solutions.
Understand customer needs and develop high-quality presentations, proposals and software demonstrations that speak of these needs.
Provide suggested enhancements to the Life Sciences Product Management & Engineering team based on customer feedback and industry trends
Collaborate with the project manager to define the project plan, risk mitigation plan, quality checklists and regularly communicate status to the project manager.
Proactively identify issues and implement preventive / remedial measures
Understand requirements, assist client facing team members in envisioning and documenting the application architecture, conduct detailed design, determine level of effort, plan work breakdown structures and implementation approach
Acquire OpenText Proven Certification in Documentum Content Management and Life sciences domain
Monitoring changes to global Regulatory Mandates from the various regulatory authorities (FDA, EMA etc.)
Excellent grasp of Documentum Life Sciences Suite and the value proposition it offers to customers
Must have at least 3yrs of recent development experience in Documentum with at least 2 years in either LSQM, LSRD, eTMF or SSV.
At least 3 years of experience in technology consulting, enterprise & solutions architecture and architectural frameworks -
Thorough knowledge on D2 Development & Configuration
Knowledge on Quality & Manufacturing and Regulatory is a must
Solid understanding & experience in GxP, eCTD, GAMP and delivering validated applications (21 CFR Part 11)
Knowledge of Regulatory Affairs, RIM, Compliance and Validation, Quality assurance / systems and life sciences and pharmaceutical industry in general.
Strong Enterprise Architecture and Integration consulting skills.
Proficient in techniques for performance testing and tuning RDBMS query performance
Strong planning and analytical skills combined with ability to work with geographically distributed teams in a rapid development model
Excellent communication skills and an ability to present complex technical topics in a manner non-technical stakeholders can easily understand
Good team motivation skills