Lead Documentum Life Sciences Consultant 1

2 weeks ago

Remote, Canada opentext Full time

**OPENTEXT - THE INFORMATION COMPANY**

As the Information Company, our mission at OpenText is to create software solutions and deliver services that redefine the future of digital. Be part of a winning team that leads the way in Enterprise Information Management.

**The Opportunity**:
Relevant experience in the pharmaceutical/biotechnology industries including document management processes and/or computer validation is a plus.

Effective at influencing and convincing others into action and able to be a good team member/player.

Able to understand and articulate customer’s viewpoints and perspectives, the problems, challenges and opportunities customers face in their business and how customers use or could use the products to address them.

Understanding of life sciences industry regulations such as 21 CFR Part 11, GxP’s, GAMP, ICH and the like is a plus.

Understanding of Regulatory Mandates from the various regulatory authorities (FDA, EMA, JMHLW, etc.) is a plus
- Documentum Content Server
- Documentum D2
- Open Text Documentum Life Sciences Suite (R&D, SSV, Q&M and eTMF)
- Brava
- Content Transformation Services

**What You will be do**:

- Leading a team of technical architects and consultants
- Work with project managers and providing inputs during planning phase
- Leading workshops and customer meetings to gather to gather requirements with customers and other technical leads.
- Leading quality outputs for solution implementation planning, design, configuration, development, testing and overall technical delivery within a project’s timeline
- Authoring project documentation including: Functional User Requirements, Configuration Specifications, User Requirements, Validation Test Scripts (IQ/OQ/PQ), Traceability Matrix, Training Materials, Meeting Minutes and Memos
- Managing deliverables and activities to completion for fellow technical team members
- Functional troubleshooting, with strong analytical skills
- Provide Technical input for RFI’s/RFP’s
- Provide suggested enhancements to the Life Sciences Product Management team based on customer feedback and industry trends and implementation experience
- Helping with the growth of existing client relationships by being a trusted advisor as a technical lead resource
- Keeping up to date with ever evolving ECM and Life Science Solution technologies

**What you need to Excel**:

- Life Sciences industry experience, with business process knowledge of document management, training management and document publishing is a plus.
- Strong team member that excels at both written and verbal forms of communication to varying degrees of audience.
- Independent, confident self-starter able to work with mínimal direct supervision
- Highly motivated and ethical
- Goal oriented to achieve business objectives
- Able to work in a matrixed team environment
- Able to travel in North America
- Having Documentum Certification is a plus

**L’occasion**:
Une expérience pertinente dans les industries pharmaceutiques / biotechnologiques, y compris les processus de gestion de documents et / ou la validation informatique est un plus.

Efficace pour influencer et convaincre les autres dans l’action et capable d’être un bon membre / joueur de l’équipe.

Capable de comprendre et d’articuler les points de vue et les perspectives des clients, les problèmes, les défis et les opportunités auxquels les clients sont confrontés dans leur entreprise et comment les clients utilisent ou pourraient utiliser les produits pour les résoudre.

La compréhension des réglementations de l’industrie des sciences de la vie telles que 21 CFR Part 11, GxP, GAMP, ICH et autres est un plus.

La compréhension des mandats réglementaires des divers organismes de réglementation (FDA, EMA, JMHLW, etc.) est un plus
- Documentum Content Server
- Documentum D2
- Open Text Documentum Life Sciences Suite (R&D, SSV, Q&M et eTMF)
- Brava
- Services de transformation de contenu

**Ce que vous ferez**:

- Diriger une équipe d’architectes techniques et de consultants
- Travailler avec les gestionnaires de projet et fournir des commentaires pendant la phase de planification
- Diriger des ateliers et des réunions avec les clients à rassembler pour recueillir les exigences avec les clients et d’autres responsables techniques.
- Principaux extrants de qualité pour la planification de la mise en œuvre de la solution, la conception, la configuration, le développement, les tests et la livraison technique globale dans les délais d’un projet
- Création de la documentation du projet, y compris les exigences fonctionnelles de l’utilisateur, les spécifications de configuration, les exigences de l’utilisateur, les scripts de test de validation (IQ / OQ / PQ), la matrice de traçabilité, le matériel de formation, les procès-verbaux de réunion et les notes de service
- Gérer les produits livrables et les activités à terme pour les autres membres de l’équipe technique
- Dép

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