Project Manager- R & D 4315BC
VeristaAbout the role
Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged
- We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Verista is currently seeking Validation Engineers with experience in facilities, equipment and process validation within a pharmaceutical or biotechnology manufacturing environment to support CQV (Commissioning, Qualification & Validation) activities.
The Project Manager will join the IT/Capabilities PMO and manage and drive key initiatives within the 2023 Capabilities Portfolio. The Project Manager will work in close coordination with Company’s Project Management Office, Strategic Technology leads and with third-party implementation partners to deliver assigned projects. The Project Manager will be responsible for overseeing the planning, execution, and delivery of large-scale projects for Company, driving timelines, tracking issues and risks. The Project Manager will be responsible for the following projects:
Location:remote
Project/Domain Overview:
- 1. Bachelor’s Degree in sciences or engineering.
2. Minimum five years of experience in an R&D IT and/or R&D PM role.
3. Proficient understanding of R&D clinical process, in the biopharmaceutical industry. Experience with late-stage development, marketed products, and/or managing collaborations is a plus.
4. Outstanding ability to communicate effectively both verbally and in writing; ability to communicate to a broad range of stakeholders.
5. Experience working with R&D Clinical applications (e.g CTMS, eTMF, or Veeva Clinical Suite); ideally some experience with Veeva migrations.
6. Good understanding of GxP process.
7. Work is related to consolidation of platforms due to the acquisition of Reata (will include both migrations and retirement efforts)
8. PM is anchor for the project; Develop complete project plan(s), manage timeline, escalations, drive the project activities
9. Work closely with business to coordinate overall effort, including all meeting scheduling, supporting testing efforts, any critical action items follow-up.
10. Ability to work independently, navigate ambiguity, adapt to change and make rapid, disciplined decisions to enable agile execution.
11. Commitment to a customer-first culture and motivation to solving complex problems and leading teams to success.
12. Proven ability to network and collaborate across multiple teams with flexible, positive attitude and ability to get results.
13. Proficiency with collaboration tools (e.g. Microsoft Office, MS Teams, O365 Sharepoint)
14. Should be available in EST hrs (8:00 AM to 5:00 PM)
Requirements
Specific PM activities:
- BA/BS Degree or equivalent work experience
- At least 8 years of experience in project management,
- Must be a driver to progress project forward. The Project Manager should be highly organized and be able to communicate well.
- Must be able to manage financial projections, actuals and estimates at completion.
- Must be able to report on project health at multiple levels.
- Prior experience in Pharma field
- Drive planning activities, develop and maintain the project plan
- Define cadence of project team meetings
- Conduct project meetings and maintain mutual interaction with project team members, leaders, staff, vendors, and consultants
- Identify project and application risks, confirming mitigation and contingency plans are in place for identified risks in order to reduce the risk of failure and support success of the project. Escalate risks as required.
- Track and monitor project issues and escalate as required
- Maintain the RAID Log
- Work with all teams to understand, plan and manage dependencies between activities.
- Ensure resource allocations and escalate resource deficiencies
- Provide weekly and monthly status updates to key stake
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