Sr. Medical Writer position
Job Description
Title: Senior Medical Writer
Reporting To: Director, Medical Writing
Looking for a Senior Medical Writer to join a three-person medical writing group responsible for clinical and nonclinical regulatory documents ( e.g. study protocols, Investigator Brochures, Clinical Study Reports, Annual Reports, INDs, and NDAs) as well as clinical and nonclinical publications (e.g. abstracts, posters, and manuscripts). This position will assume lead writing responsibility on up to 5 clinical studies potentially leading to an NDA, including both regulatory and publication documentation. This potion will also lead writing assignments on other programs in early development.
Responsibilities:
oWrites clinical protocols, clinical study reports, investigator's brochures, annual reports, INDs, IMPDs, and NDAs and other regulatory documents in conjunction with the project team with minimal supervision
oWrites, reviews, and/or edits publications (manuscripts, abstracts, poster presentations, etc.)
oDrives document writing and review processes
oDevelops and maintains timelines for document generation, revision, and completion, with collaboration with other study team members
oCoordinates and manages review cycles, incorporates team comments, and leads discussions on document revision and finalization
oMay manage outsourced writing projects with minimal supervision
oAssists in the development and maintenance of SOPs and writing tools, such as templates and style manuals
oProvides training on medical writing templates, SOPs, and processes within the department and across departments
oContributes to the development of electronic document systems and tools
oProvides quality control (QC) review of various regulatory and medical communications documents
oProvides project team(s) with guidance and problem resolution related to document generation
oTakes the initiative to solve problems, exercising sound judgment and appropriate flexibility within a dynamic environment
oActs as an authoritative resource within specialty area to internal and external resources
oWorks effectively with colleagues from other departments in team situations
Minimum Requirements:
oBS/BA, MS/MPH/MA, or PhD in a scientific or medical discipline or equivalent with a minimum of 5 years of medical writing/editing experience in the pharmaceutical/biotechnology industry or CRO environment.
oProven ability to act as lead author on different types of clinical and regulatory documents
oProven ability to understand and summarize clinical data
oExpertise in MS WORD, including the ability to solve technical problems with documents and templates
oKnowledge of FDA and ICH guidelines
oExcellent grammatical and communication skills, both written and oral
oBasic knowledge of science and clinical research
oHigh level of professional expertise through familiarity of industry trends for clinical documents and international dossier preparation, including electronic document submissions
oExperience working on complex projects, within cross-functional teams
Estimated Salary: $20 to $28 per hour based on qualifications.
Title: Senior Medical Writer
Reporting To: Director, Medical Writing
Looking for a Senior Medical Writer to join a three-person medical writing group responsible for clinical and nonclinical regulatory documents ( e.g. study protocols, Investigator Brochures, Clinical Study Reports, Annual Reports, INDs, and NDAs) as well as clinical and nonclinical publications (e.g. abstracts, posters, and manuscripts). This position will assume lead writing responsibility on up to 5 clinical studies potentially leading to an NDA, including both regulatory and publication documentation. This potion will also lead writing assignments on other programs in early development.
Responsibilities:
oWrites clinical protocols, clinical study reports, investigator's brochures, annual reports, INDs, IMPDs, and NDAs and other regulatory documents in conjunction with the project team with minimal supervision
oWrites, reviews, and/or edits publications (manuscripts, abstracts, poster presentations, etc.)
oDrives document writing and review processes
oDevelops and maintains timelines for document generation, revision, and completion, with collaboration with other study team members
oCoordinates and manages review cycles, incorporates team comments, and leads discussions on document revision and finalization
oMay manage outsourced writing projects with minimal supervision
oAssists in the development and maintenance of SOPs and writing tools, such as templates and style manuals
oProvides training on medical writing templates, SOPs, and processes within the department and across departments
oContributes to the development of electronic document systems and tools
oProvides quality control (QC) review of various regulatory and medical communications documents
oProvides project team(s) with guidance and problem resolution related to document generation
oTakes the initiative to solve problems, exercising sound judgment and appropriate flexibility within a dynamic environment
oActs as an authoritative resource within specialty area to internal and external resources
oWorks effectively with colleagues from other departments in team situations
Minimum Requirements:
oBS/BA, MS/MPH/MA, or PhD in a scientific or medical discipline or equivalent with a minimum of 5 years of medical writing/editing experience in the pharmaceutical/biotechnology industry or CRO environment.
oProven ability to act as lead author on different types of clinical and regulatory documents
oProven ability to understand and summarize clinical data
oExpertise in MS WORD, including the ability to solve technical problems with documents and templates
oKnowledge of FDA and ICH guidelines
oExcellent grammatical and communication skills, both written and oral
oBasic knowledge of science and clinical research
oHigh level of professional expertise through familiarity of industry trends for clinical documents and international dossier preparation, including electronic document submissions
oExperience working on complex projects, within cross-functional teams
Estimated Salary: $20 to $28 per hour based on qualifications.
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