Senior Manager Medical Affairs

JOB DESCRIPTION:

MAIN PURPOSE OF ROLE

• Leads/supervisesateamofmorethan2professionalswithintheMedical Affairs Sub-Function.

  
  

• Firstlevelmanagerofaworkteamthatmaycompriseprofessionals,technicaland/oradministrativestaff.

  
  

• Typicallywithoutbudgetorhire/fireauthority.

  
  

• Focusesonmentoring,coaching,andcoordination.

  
  

MAIN RESPONSIBILITIES

• AstheSupervisoroftheMedical Affairs Sub-Function,supervisesprofessionalsinoverseeingthedirection,planning,execution,clinicaltrials/researchandthedatacollectionactivities.

  
  

• Contributestoimplementationofclinicalprotocols,andfacilitatescompletionoffinalreports.

  
  

• Recruitsclinicalinvestigatorsandnegotiatesstudydesignandcosts.

  
  

• Responsiblefordirectinghumanclinicaltrials,phasesIII & IVforcompanyproductsunderdevelopment.

  
  

• Participatesinadverseeventreportingandsafetyresponsibilitiesmonitoring.

  
  

• Coordinatesandprovidesreportinginformationforreportssubmittedtotheregulatoryagencies.

  
  

• Monitorsadherencetoprotocolsanddeterminesstudycompletion.

  
  

• Coordinatesandoverseesinvestigatorinitiationsandgroupstudies.

  
  

• Mayparticipateinadverseeventreportingandsafetyresponsibilitiesmonitoring.

  
  

• Mayactasconsultant/liaisonwithothercorporationswhenworkingunderlicensingagreements.

  
  

QUALIFICATIONS

Education

• Associates Degree (± 13 years)

  
  

Experience/Background

• Minimum4years

  
  

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:Medical & Scientific AffairsDIVISION:EPD Established PharmaLOCATION:India > Mumbai : BKC BuildingADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 15 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Keyboard use (greater or equal to 50% of the workday)