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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Sales / BDSBU Head / CEO / Director |
| EmploymentType | Full-time |
Responsible for providing medical and scientific leadership into medical brand teams and other brand related functions from pre-launch through Life Cycle Management. WW MA Director supports the WW BMDs in the execution of MA activities in alignment with GMA functions. For assigned MA studies (Phase IIIB-IV, PMS, non-interventional studies without regulatory impact) within program/brand, WW MA Director provides medical/ scientific input to: Key activities related to planning, execution & reporting of Global MA studies & ensure timely & on budget delivery Contribute to study-related documents (concept sheets, protocols, case report forms, statistical plan, study reports)
Develop & review presentation material for study/program-related advisory boards, investigator meetings, protocol training meetings & external speaker at meetings Review clinical study data, analysis & interpretation with Brand Safety Leader, Global Clinical Team(GCT) members & GBT(Global Brand Team) Serve as disease area scientific/ medical expert for internal stakeholders, other line functions within GMA & ext. customers
Support on MA Plan & other lines functions plans (CDP, IPS); scientific content of Program/brand publication plan to ICE Medical Franchise Head & related support in PLS (Product Lifecycle Service); to prepare Global guidance documents, for Medical Science Liaisons, in Periodic Safety Update Reporting (PSURs) & Development Safety Update Reporting (DSURs) Support data mining & Real World Evidence activities Provides support to WW BMD & to ICE Medical Franchise Head or deputize in selected cases for internal/ external medical education & communication initiatives
Act as MSL POC with GMAT & provide compound and disease area-related scientific training & materials to MSLs Channel GMAT deliverables to MSLs as per Regional Medical Directors/ Franchise Heads Provide input to MSL materials & related activities & supports development of these deliverables along with ICE Medical Franchise Head Provide input for assigned program/brand to develop IPS, MA strategy & related MA plan Develop Clinical Development Plan (CDP section related to MA activities) Lead MAST (Medical Affairs Study Team) to provide guidance to CPOs
Provide input to brand safety activities for assigned program; PSURs/DSURs; in compliance of promotional & non-promotional global material Deputize for WW BMD in Global Clinical Team (GCT), Global Project Team (GPT), Global Brand Team (GBT), Clinical Development Unit (CDU), CPO WebEx Alignment meetings & internal decision boards as MA advocate Talent development of MA & Development colleagues like ICE Medical Franchise Head, Field Medical Experts & Clinical Trial, through participation in on-boarding, training & mentoring activities.
Minimum requirements
MD, Pharma D or PhD with knowledge and experience in medical affairs activities, with 6 years of clinical research or Global Medical Affairs experience required preferably in the Health Industry.
Fluent English (oral and written) Advanced medical/scientific writing and communication skills. Proven ability to interpret, discuss and represent efficacy, statistical and safety data relating to the assigned area.
Proven ability to work both independently and in a cross functional team setting, including a highly-matrixed environment. Demonstrated ability to establish strong scientific partnership with key investigators in assigned TA. Medical and/or scientific expertise within a disease area required.
,Keyskills :
ips bmd pms ice linicaldevelopment dataanalysis kolidentification advisoryboards medicalaffairs clinicaltrial lifecycle clinicalstudy casereportforms scientificwriting statementsofworksow clinicalresearch professionalliability medicaleduc