Consultant/Project Manager

SummaryThe Senior/Consultant/Project Manager will function as an integral part of the Client Services Team to assist clients installing and using Liquent?s industry-leading software (CoreDossier, EZSubs, Insight Suite, RenderPerfect, etc.).

The Senior Consultant/Project Manager will work in the Consulting Services Organization, serving on domestic and global implementations of Liquent?s suite of publishing and content management applications and tools. This individual will be engaged in varying Consulting roles, including some Project Management engagements. The role requires regular and ongoing work with internal teams and external clients.
DescriptionESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

- Assist and serve as a senior consultant on client engagements, running various workshops including requirements gathering, business process to application mapping, regulatory submissions / operations best practices, and configuration of the application to fulfill requirements.
- Consult with clients regarding regulatory submission strategies (eCTD and paper), submission planning/tracking, and registration planning/tracking.
- Support the pre- and post-post sales strategies for potential client engagements.
- Maintain a strong understanding of relevant industry regulations, helping to educate on latest updates and relevance.
- Serve additionally in a wide array of consulting roles as required/available, such as eCTD readiness assessment consultant and lead consultant on Operational Qualification (OQ), and Performance Qualification (PQ) validation activities.
- May serve in some Project Manager roles on client engagements, responsible for project resources, developing and tracking project plans and budgets, and guiding the client relationship throughout the engagement to ensure positive outcomes.
- May manage internal CSO associates, responsible for coaching the associates in their careers, authoring and delivering feedback/reviews, etc.

QualificationsDesirable qualifications/experience:
- Strong organizational and interpersonal skills with a customer focus, including public speaking in formal and informal educational environments.
- Experience with Life Sciences industry and guidelines, such as GxP, GAMP, 21 CFR Part 11, CSV standards and typical protocols of IQ/OQ/PQ.
- Experience with end to end submission processes for key global agencies (i.e., FDA, EMEA, CA and Japan).
- Project management (or team leader) experience.
- Experience with software implementation projects.
- Proficiency working in Microsoft Windows environment and with Windows-based applications including Microsoft Office products, Adobe Acrobat, desktop publishing and graphics packages.
- Experience with Document/Content Management Systems.
- Experience with CoreDossier and EZsubs or other Liquent products considered a plus.
- 4-year college degree or technology-related discipline.

LANGUAGE SKILLS

- Excellent written and oral business communication skills
- Excellent English communication skills. Multi-lingual skills a plus.