No.of post: 02

Job Description
* Lead the Clinical Support division & plan Sponsor audits of BA/BE studies; Patient based PK studies & Clinical end-point studies.
* Evaluating complexity of products, in-vitro dissolution data & correlation to the invivo
behavior of the formulation to enhance success in bioequivalence studies
* Providing Clinical Development strategy, Investigation of BA/BE study results,
IVIVC Correlation & designing of Pilot & Pivotal Bioequivalence studies.
* Manage the budget & outsourcing of bio-studies to Clinical research organization
(CRO) & oversee compliance to GCP, GLP, SOP(s), Protocols and Regulations
* Manage bio-study from initiation to the availability of e-CTD module-5 for ANDA.
* Coordination with Analytical, Formulation, Regulatory & Project management
* Assist BD activities for the USA, Asia Pacific & South-East Asian territories
* Manage the out-licensing portfolio, evaluate business opportunities and access to potential customers for contract research projects, contract ANDA & dossier development, CRAMS Activities, BA/BE and Clinical Trials.

Candidate Profile
– Clinical, GCP,
– Bio-analytical, GLP
– Pharmacokinetics and Statistical evaluation and review
– Bio pharmaceutics
– In-vitro In-vivo correlation (IVIVC).
– Understanding of Bio-complexity of the Generic products and strategy/decision making in BA/BE studies
– Investigation of Bio-studies results

Additional Information:
Experience: Above 9 years
Education: M.Sc/M.Pharm
Industry Type: Pharma
Location: Ambernath
Salary: Up to 12 L
Functional Area: CR
Last date: 18th November, 2016

If you are interested then send your updated CV in word format onĀ with following details –

Total Experience
Current CTC
Expected CTC
Notice Period
Team Size