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Assistant Mgr / Deputy Mgr Scientific Affairs

3.00 to 8.00 Years   Mumbai City   08 Mar, 2021
HRDHouse
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Roles and ResponsibilitiesYou will be based at a Corporate office at Mumbai.You will be responsible for:Product Launch

  • New Product Launch Presentation to the Marketing team and to the field with technical
New Product Ideationo Evaluate and suggest novel products, indication expansion, unique dosage form.Scientific Support to the Brands
  • Keep abreast of the latest scientific information on products, therapy areas, landmark trials,
guidelines from scientific associations on therapy areas.
  • Provide technical support to the Marketing/Sales Department in terms of references on
new as well as existing products.
  • Validate medical content in marketing inputs for accuracy and high scientific quality.
Trainingo Dissemination of medical information by conducting training programs for fresher and refresher course for medical representatives.Regulatory Affairso Licensing of new products for domestic market (DCGI/FSSAI) - Involves coordination with R&D, QA department, CROs for submission of dossiers for product registration.o Provide technical backup to CROs/R&D/QA department for preparation of regulatory documents for domestic and international market.Responding to Querieso Ensure good customer relations by addressing queries from field force and doctors alongwith relevant scientific support.Clinical Trialso Prepare and review the protocol and CRF for conducting Phase III / IV trials and PMS.Pharmacovigilance
  • Responsible for Medical writing, Case processing, Quality review, PSUR Writing, Literature
searches & review and Compliance. Desired Candidate ProfileCandidate should be M. Pharm with 4 years of experience in a pharma company into Scientific Affairs / Medical Affairs.-You should be good in Present the product to the Marketing team and launch to the field and Preparing CME Modules.-You should have experience in Providing medical rationale (Justification) for new product introductions and Providing technical support to the Marketing/ Sales Department in terms of references on new as well as existing products.-You should have experience in conducting training programs for fresher and refresher course for medical representatives and Sourcing latest medical data.-You should have experience in Licensing of new products for domestic market (DCGI/FSSAI) - Involves coordination with R&D, QA department, CROs for submission of dossiers for product registration. Also Provide technical backup to CROs / R&D / QA department for preparation of regulatory documents for domestic and international market. ,

Keyskills :
medical writingpsur writingcase processingiiiphase iiicrfsalesproduct launchtrialstechnical supporttherapycustomer relationspharmatraining programswritingpsurcmemedical

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