Job Description

Job Title: Senior Business Consultant Pharma CMC
Location : East Coast TCS locations
Travel: 25%

Experience: 14+

:

1. 15+ years of experience with pharma pre-clinical and clinical labs and relevant data management, biostatistical analysis, regulatory affairs
2. 10+ Years of experience with industry standard processes and solutions for CMC in labs direct FDA/EU regulatory experience is required. Experience with guidelines e.g. ICH is required.
3. Experience with solid and liquid dosage forms and across large and small molecules is required
4. 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.
5. Strong technical writing, presentation and articulation skills; Excellent communication on the ways technology is deployed in pharma manufacturing and supply chain
6. Ability to lead with the client digital transformation team; contribute to proposal developments
7. Hands on experience with at least one analytical environment
8. 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
9. Develop and maintain relationship with target and client executives
10. Coordinate development activities collaboratively with customer teams and offshore teams
11. Collaborate with organization sales team on providing proposed solution and architecture for pre-sales discussions in areas of pharma labs
12. Ability to lead and coach technical and business development team
13. Collaborate in identifying, assessing, and selecting innovative ideas from internal and external sources based on their value proposition
14. Ability to work collaboratively with global delivery team
15. Self-motivated person with moderation and persistence skills

Responsibilities:

1. 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
2. Bring solid executive presence and domain expertise for supply chain, manufacturing; clinical data management, biostatistical analysis, regulatory affairs or pharmacovigilance a plus
3. Develop and maintain relationship with target and client executives









Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.