Excellis Health Solutions, LLC, an NNIT Group Company, is a global strategic management consulting services firm, based in New Hope, PA, England, Belgium and Denmark. An industry leader in supply chain, with a focus in Pharmaceuticals and Life Sciences and a specific niche in serialization, we offer a multitude of solutions using our comprehensive knowledge and proven turnkey solutions to clients. Excellis continues to expand its markets and services to meet the ever-changing industry needs. With 70+ employees and historical growth of 25% plus year over year, Excellis anticipates continued growth in the United States and in Europe.
Job Summary
The Senior Consultant is expected to provide strategic consulting support and subject matter expertise to clients through various types of engagements impacting Product Launch activities. The Senior Consultant will be responsible for owning specific tasks, objectives, and deliverables when engaged with clients on a specific project. Excellis engages with Manufacturers (Virtual and/or Manufacturers with sites) to provide a First-Time Launch Playbook and any resulting efforts in order to assist in gaining approval of their first product in their first market, having a successful launch, and transitioning from a clinical organization to one with complete commercial capabilities. The First-Time Launch support covers ten key functional areas within the Life Sciences including Clinical, Quality, Regulatory, Manufacturing, Packaging, Supply Chain, IT, Finance, Human Resources, and Commercial. Excellis defines To-Be Processes for each functional area as organizations prepare to launch and then provide services to implement the supporting programs and/or technologies that align with the clients requirements. The Senior Consultant will provide strategic support and guidance within their area of expertise throughout the First-Time Launch engagement with the customer. The Senior Consultant is required to work collaboratively with customer stakeholders and the internal Excellis team which could include Executive Leadership, Project & Program Managers, and other SMEs / Consultants.
Duties and Responsibilities:
Review of clients existing processes documenting As-Is state as a clinical organization and establish To-Be processes to support Pre and Post Launch Activities
Develop First-Time Launch Playbooks and Strategies for each assigned client
Assist with the development of key strategy documentation for a First-Time Launch program
Lead RFP process for the required Partners and/or Technologies identified during the Strategy
Develop client specific requirements to evaluate, select, and contract with the best fit Partners / Vendor
Support with Implementations and Execution of projects identified within the assigned workstream
Provide industry / workstream specific subject matter expertise and training to client
Lead breakout sessions and workshops focused on the assigned workstreams
Maintain a comprehensive understanding of the associated business and compliance requirements to bring a product to market in the US
Work with the project team to develop any required project documentation to support client deliverables
Provide expertise in developing required SOPs to support current and future operations
Define Center-of-Excellence at the client for the Implemented Technology / Partner / Program
Support Business Development team to draft SOWs including scope and estimated hours
Provide introductions to your existing network to initiate Business Development Opportunities
Qualifications and Education Requirements:
Bachelors degree, Masters Preferred
Knowledge of the Life Sciences Industry and specifically the Product Launch Process
Ten Years (10) years of experience supporting various areas of the Life Sciences industry (ex. Clinical, Quality, Regulatory, Manufacturing, Packaging, Supply Chain, IT, Finance, Human Resources, and Commercial)
Five (5) years of supporting Life Sciences Organization(s) with Product Approval & Launch activities
Experience with Implementations of business-critical technologies such as ERP, QMS, eDMS, MDM, EPCIS / Serialization, RIMS, eTMF, CTMS, etc.
Familiarity and Expertise with the effort needed to transition from a clinical organization to one that has approved pharmaceutical product
In-depth understanding of various industry / FDA compliance requirements
Preferred Skills and qualifications:
Proven success providing support through the First-Time Launch Process
Results oriented with the ability to organize, prioritize, and work on multiple projects simultaneously while managing project schedules and deliverables
Thorough understanding and utilization of technology (i.e., Microsoft Office 365 Suite) in everyday performance
Excellent verbal and written communications skills
Self-motivated, organized, and focused to ensure successful remote work environment
This is a client facing position, so professional appearance is required
Willingness to travel up to 20%
Benefits
Excellis Health Solutions offers a comprehensive benefits package including:
Competitive Salary
Medical, Dental, Vision Insurance
401K
8 Paid Holidays and 2 Floating Holidays annually
2 Weeks of annual Paid Time Off
Compensation Structure:
Salary:
Bonus:
Required Training: Familiarization with the following helpful. Training will be required if no previous knowledge.
Microsoft Office, TEAMS, SharePoint, BigTime, SmartSheet, Life Sciences Supply Chain, Life Sciences Processes and Technologies