POSITION SUMMARY: Glenmark is leading transnational player focused specifically on development of NCEs/NBEs. In order to support organization vision of becoming truly integrated Innovation led company its essential that R&D systems footprint remains up-to date with current & emerging technologies. Techno-Functional Lead (Project Coordinator) will be responsible for Evaluation, Assessment, Implementation (delivery) & Sustenance of enterprise business applications around Manufacturing, R&D/Clinical Development domain. The additional responsibilities include working on business proposals including solution design, stakeholder co- ordination, industry trends and competitor analysis and prepare business case to facilitate system deployment. OVERALL JOB RESPONSIBILITIES: 1. Preparation of Business Proposal, Business Process mapping, Project Management, Solution Architect 2. Initiation, Preparation, Design, Implementation & support of Business applications. 3. Stakeholder Management (Internal & External) 4. Internal - Functional/Operation Teams 5. External - Tech Partners, Suppliers/OEMs, System Integrator 6. Documentations & Training RESULTS EXPECTED/ TARGET: 1. End to End project management (delivery) - On-time delivery within budget & quality 2. Vendor relationship management & Governance - 100% 3. Ensuring 100% company compliance with Pharma Lifesciences practices on CSV and dynamic regulations/mandates KNOWLEDGE, SKILLS AND ABILITIES: Education (degree / diploma): Bachelors in Engineering (Preferred) Experience: 8-12 years in pharma product based companies Knowledge and Skills (Functional / Technical): 1. Business Analyst, Project Management Enterprise content management and regulatory document management. 2. Regulatory Applications Management, Regulatory Affairs & Compliance, Audit Support. 3. Track & Trace Serialization SME Pharma R & D, PV, Clinicalmse 4. Technical Operations. 5. Business Technology delivery and implementation, Process mapping and de- nition. 6. Drug Regulatory Application Functional SME. 7. Pharmacovigilance drug safety. 8. Designing Solution architecture. 9. Bio-equivalence (BE) Process SME. 10. Database Technologies (Oracle, SQL). 11. CSV - 21CFR Part 11, EU Annex. 12. TraceLink & RFXCEL Administrations, Antares Administration & Solution Message flow designing.

Mumbai

Glenmark Pharmaceuticals - Manager - IT - Pharma Regulated Applications 

Glenmark Pharmaceuticals - Manager - IT - Pharma Regulated Applications  ,Job Description for Glenmark Pharmaceuticals - Manager - IT - Pharma Regulated Applications  in Glenmark Pharmaceuticals in  Mumbai for (8-12) years of experience. Apply Now!

Job Description for Glenmark Pharmaceuticals - Manager - IT - Pharma Regulated Applications  in Glenmark Pharmaceuticals in  Mumbai for (8-12) years of experience. Apply Now!