Medical Writer, Contractor

Location – Cranbury , NJ

 

 

 

SUMMARY OF POSITION

 

TheMedical WriterContractorwill focus on thepreparation, assembly, writing, and review ofthe analysesand documentation neededin support of clinical trials and correspondingsubmissions to regulatoryauthorities.

 

 

 

MAJOR ACTIVITIESAND RESPONSIBILITIES

 

Responsibilities mayincludebut arenot limited to:

 

  • Preparationofclinicalstudyreportsorotherregulatorydocumentssupportingongoing clinicaldevelopmentprogramsand theirsupportiveappendices(orsectionsofthese)by theincorporation oftext, graphs, charts,tables, statisticalanalyses,etc. in aclearand accuratemannerconsistent withthetargetaudienceand regulatoryrequirements.
  • Consolidation andevaluation ofteammates’ reviewcomments to determineneeded revisions
  • Reviewingstatisticalanalysisplansandaccompanyingtableand listingshells forthe evaluationand presentationofclinicaltrialdata
  • Quality-checkingdocuments foragreementbetween in-text information and thesource data
  • Editorialreviewofdocumentsforgrammar, punctuation, and submission-compliant formatting
  • Provideoverallmedicalwritingsupportforongoingprograms

 

Relianceon instructions,templates, and pre-established guidelines will be expected to perform theabove functions.

 

 

 

 

ORGANIZATIONALSTRUCTURE

 

TheMedicalWriterContractorreportsto the ManagerofMedicalWriting.

 

 

QUALIFICATIONSAND BACKGROUND REQUIREMENTS Educational Requirements

 

  • Mastersdegreein ascientificdisciplineplusaminimumof2-5yearsindustryexperience.
  • Ph.D,Pharm.D,orequivalentin a scientificdiscipline plusa minimumof1-2yearsindustry experience.

 

Professional WorkExperience

 

  • Theidealapplicant would have trainingin thebiomedicalsciences, particularlyinareas such asbiology, pharmacology, chemistryand biotechnology, aswellasexperience in technicalwritten communication.
  • Agood understandingofmedicalterminologyisalso needed.
  • Thisposition requirestranslatingtechnicalinformationfrom mixed sourcesintowritten informationsuitableforanaudienceofregulatoryauthoritiesand clinicians.Itwillbe essentialtoapproachissuesfromanumberofperspectives, summarizingdata todrawa conclusion.
  • Applicantmustbeableto preparedeliverablesin accordancewithpre-established timelines, systematicallyperformingactivitiesin atimelyand accuratemanner.
  • Advanced writingandspeakingcompetency, positiveand proactivecommunication skills,proficiencywithMicrosoftOfficeSuite.
  • High attentionto detail.

 

 

 

 

Compensation

 

ThisisaContractposition