Location: East Coast (Travel: 25%) Duration: Fulltime Position
:- Technical/Functional Skills- Experience-14+ years
15+ years of experience with pharma pre-clinical and clinical labs and relevant data management, biostatistical analysis, regulatory affairs
10+ Years of experience with industry standard processes and solutions for CMC in labs \xe2\x80\x93 direct FDA/EU regulatory experience is required. Experience with guidelines e.g. ICH is required.
Experience with solid and liquid dosage forms and across large and small molecules is required
Proven project and program management experience with end to end responsibility a plus. Processes to include pre-formulation and formulation studies, analytical methods design, ICH stability and compatibility, and dosage form design.
Strong technical writing, presentation and articulation skills; Excellent communication on the ways technology is deployed in pharma manufacturing and supply chain
Ability to lead with the client digital transformation team; contribute to proposal developments
Hands on experience with at least one analytical environment
Experience of presenting solution design with customer clinical/scientific/technical stakeholders, driving business analyst process like requirement specification, functional requirement to technical requirement transformation and documentation
Develop and maintain relationship with target and client executives
Coordinate development activities collaboratively with customer teams and offshore teams
Collaborate with organization sales team on providing proposed solution and architecture for pre-sales discussions in areas of pharma labs
Ability to lead and coach technical and business development team
Collaborate in identifying, assessing, and selecting innovative ideas from internal and external sources based on their value proposition
Ability to work collaboratively with global delivery team
Self-motivated person with moderation and persistence skills
Responsibilities:
Lead solution design with customer clinical/scientific/technical stakeholders, driving business analyst process like requirement specification, functional requirement to technical requirement transformation and documentation for pharma labs
Bring solid executive presence and domain expertise for supply chain, manufacturing; clinical data management, biostatistical analysis, regulatory affairs or pharmacovigilance a plus
Develop and maintain relationship with target and client executives
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