Sr. Specialist Medical Affairs (Temporary)

Job Description

SeniorSpecialistMedicalAffairs

This position is under the supervision of an Associate Director and is responsible for operational activities related to study planning study execution and the summarization of results from observational research studies and related activities.

ResponsibilitiesandPrimaryActivities

• Coordinates the end-to-end process for executing observational or non-interventional research studies in compliance with Good Pharmacoepidemiology Practice and research-related standard operating procedures (SOPs).

• CollaborateswithcolleaguesacrossV&Itosupporttheleadscientistsinoveralloperationalsupportforstudyconduct.

• Provides study-level management support which includes the execution of appropriate service forapprovedproposals/scopesofwork(includingthereviewofrequestsforinformation/proposaldraftscopeofworkwhere applicable) confidentiality and consultant agreements and subsequent amendments/change orders.

• Participatesinprotocolandinterim/finalreportpreparationandliteraturereviewabstractionandsummarization.

• Coordinatesthereviewandfinalizationofallvendordocumentssuchassafetymanagementdatamanagementcommunication project management and validation plans.

• Tracksstudytimelinesanddeliverablesandfollowsuponactionitems.

• Collaboratesextensivelyandtroubleshootsissuesbyprovidingpotentialresolutions(whennecessary)withinternalandexternal partners ensuring timely study management and execution.

• Assistsintrackingstudymilestonesandtimelines.

• Liaiseswithoutsourcedvendorsandcross-functionalteamstocommunicateandoverseeprojectstatusand/orneeds.

• ProvidessupplieroversighttoensurealignmentwithallSOPsandotherinternal/externalrequirements.

• Participatesinquality-controlassessmentsandensuresintegrityofstudydataforreportsandpublications.

• Understandscoordinatesanddocumentsadherencetointernalexternalandregulatorycompliancerequirements.

• Utilizesmanagesandmaintainsdocumentrepositoriesandinternal/externalsystems.

• Provides operational support for due-diligence checks site contract and budget review/approval informed consentstudyregistrationinformationtechnology(IT)and/orprivacyassessmentsvendorqualificationadverse-eventreportingand reconciliation and publication submissions.

• Managesposterandpublicationdevelopmentincludingformattingmedicalwritingfigure/datacontentdevelopmentco-author review internal-review process and journal submissions.

RequiredQualificationsSkillsandExperience

• BachelorsdegreeinNursingBiologyPublicHealthorhealth-relatedorsciencediscipline.

• 2yearsofworkexperiencewithinclinical/observationalresearchorequivalentexperience.

• Knowledgeofepidemiologicoroutcomesresearch.

• AdvanceEnglish(writtenandspoken).

• Excellentcommunicationandinterpersonalskillsandtheabilitytocollaboratewithandinfluenceawidevarietyofstakeholders.

• Strongprojectmanagementandprioritizationskills.

• Understanding of digital innovation

• Abilitytoworkindependentlyandcollaboratively.

Preferred

• Mastersdegreeorspecializationinpublichealth(orcloselyrelateddisciplinesuchashealthadministrationorbiologicalsciences).

• ProjectManagementProfessionalorCertifiedAssociateProjectManagementcertification.

Required Skills:

Preferred Skills:

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