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v Publications writing
v Regulatory writing
v SOPs and manuals
v Publications writers do……
vPrepare manuscripts, abstracts, posters, slide presentations from CR&D trial data vDevelop strategic publications plans vChair publication subcommittees vCoordinate review and sign off of CR&D publications vCoordinate agency and freelance publications support vDo not write regulatory documents (CSRs, etc)
vRegulatory writers do………..
v Prepare Clinical Study Reports, Investigator Brochures, Summary Documents, Labeling v Become familiar with pertinent guidelines and regulations and company SOPs v Become capable in relevant software applications, especially word and word templates v Develop understanding of how documents relate to one another, a skill that aids in document planning and preparation v Attend meetings, serve on committees
vWriting for Compliance………… vStandard operating procedures, document preparation manuals, training materials…….
What Qualities needed for Medical
vEnthusiasm for writing - willingness to go the extra mile vAbility to gather, synthesize and critically analyze large amounts of data vExpress ideas succinctly – not “academic” documents vGood team player vScientific/medical background vExpertise in 1or 2 therapeutic areas plus willingness to learn from others
vBe prepared to have document severely “edited” by team members or investigators vDo not expect to be an author when manuscript is published vFreelancers
vShould be able to attend meetings by Management. vShould be willing to commit to a series of related manuscripts/documents
vSense of humor
vWhat Is Expected?
vAs a Medical Writer, you spend as much time chasing down details, and reconciling discrepancies as you do actually writing; vYou must have a thick skin and learn not to take criticism of your writing personally; vYou must be able to communicate with many professionals from many functional disciplines; vYou're the last one to get the information, and are often expected to work miracles in
vYou must keep up-to-date with the software used; vIf you are freelancing, you must be willing to keep the software on your PC up-to-date; vYou must be willing to ask questions; assumptions can result in time wasted; vYou must be knowledgeable about processes and style guides. vAs a Medical Writer, you need to keep current with your therapeutic area(s).