Medical Writer

Found in: Talent IN C2 - 2 weeks ago

Mon Village, India TechAveev LLC Full time

Job Title:Medical Writer

Location:Remote

Duration: 12Months

Client:AbbVie

Experience: 5yrs

JobDescription:

5plus yrs. exp in industry with medical writing will beoverqualified. Solid written and verbalcommunication skills Someone with industry expwill be considered as well. This role is notfor writing regulatory submissions.Publications writing role. Will beworking on manuscript abstract posters and journals.Fresh Phd grad will also work.Therapeutic areas: migraine neuro Parkinson diseaseAlzheimers immunology within dermatology spacePhD preferred in science field or other advanced degreewith scientific writing experience. Scientificbackground needed

Summary

The Senior Medical Writer is responsible for providingmedical writing ensuring successful preparation of highqualitydocuments and effective implementation of the writingprocess.

Provides medical writing expertise formultiple compounds and/or projects within a therapeutic area.Interfaces with crossfunctional groups to ensure accurate andtimely completion/delivery of information and review of writingprojects

Responsibilities:

Serves as medical writing lead on assignedprojects. Works closely with infunction and crossfunctional team(s)on project strategies. Implements all activities related to thepreparation of writing projects Coordinatesthe review approval and other appropriate functions involved in theproduction of writing projects. Arranges andconducts review meetings with the team.Ensures required documentation is obtained.Converts relevant data and information into a form thatmeets project requirements. Explains data in amanner consistent with the target audience(s)requirements. Effectively communicatesdeliverables needed writing process and timelines to teammembers. Holds team members accountable toagreedupon project dates and with an appropriate qualitylevel. Negotiates with functional areas onproject outcomes and deliverables to meet conflictingdemands. Identifies and proposes solutions toresolve issues and questions arising during the writing processincluding resolution or elevation as appropriate.Understands assimilates and interprets sources ofinformation with appropriate guidance/direction from developmentteams. Interprets and explains data generated from a variety ofsources. Verifies that results are consistentwith protocols. Challenges conclusions whennecessary. Understands/complies with appropriate conventions propergrammar usage and correct format requirements as needed for eachwriting project following applicable divisional guidelinestemplates and SOPs. Performs literaturesearches as needed for drafting document content. Interpretsliterature information and makes recommendations for application towriting projects. Works with journal/congressthroughout the writing process addresses questions/feedback asappropriate and works with a team to draft responses asnecessary. Knowledgeable of US andinternational regulations requirements and guidance associated withpreparation of writing projects. Learns and applies knowledge oftherapeutic areas and products to writing projects. Mustcontinually train/be compliant with all current industryrequirements as they relate to assigned projects includingsubmission/approval standards. Serves as arepresentative on project teams. Acts asSubject Matter Expert regarding computerbased technologies utilizedby the respective departments. May mentor andprovide guidance to more junior medical writers and/or externalvendors/agencies. Implements tactical processimprovements

Qualifications

  • Bachelor of Science required with relevantwriting experience or Bachelors degree in English or communicationswith relevant science experience. Advanced degreepreferred.
  • American Medical WritingAssociation (AMWA) certification or other is preferred with aspecialty in Editing/Writing or Pharmaceutical.
  • 3 years relevant industry experience in medical writingin the healthcare industry or academia required or in a relatedarea such as quality regulatory publications clinical research orproduct support/R&D.
  • 3 years experience inexperimental design and clinical/preclinical data interpretationpreferred.
  • Knowledgeable of US andinternational regulations requirements and guidance associated withpreparation of assigned writing projects.
  • Knowledge and experience working with templates andrelevant systems
  • Excellent written and oralcommunication skills. Experience in working with collaborativecrossfunctional teams including project managementexperience.
  • Ability to assimilate andinterpret scientific content and translate information forappropriate audiences.
  • Superior attention todetail. Ability to find and correct errors in spelling punctuationgrammar consistency clarity and accuracy.
  • Expert in word processing flow diagrams and spreadsheets.Excellent working knowledge of software programs in the Windowsenvironment