BioPhase
Medical Writer
BioPhase, New York, New York, United States,
BioPhase Solutions
specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a
Medical Writer
to work for a leading Greater Los Angeles area biotechnology company.
Salary:
$100-150/hr. depending on experienceOn-site or Remote1099 Contract2+ months contract w/ high chance of extension
Summary:The Medical Writer will be responsible for the preparation of high-quality regulatory documents, including clinical study reports, clinical summaries and overviews, study protocols, Investigator’s brochures, and informed consent forms. The Medical Writer may also be responsible for planning, managing, and preparing internal and external communications of key scientific and clinical data, including abstracts, poster and oral presentations, manuscripts, congress materials, and educational/training materials..
Responsibilities:Write, edit, and finalize CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents.Write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents.Write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients.Work collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documents.Lead document review meetings and discussions.Provide direction and solutions to cross-functional teams on expectations for document content.Perform QC of clinical and nonclinical documentsProvide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines.
Experience/Requirements:BS/BA in related life-science field required. (Master’s or PhD degree preferred)Experience in NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions.Strong scientific background in oncology, immunotherapy, or related fieldProficient knowledge of AMA writing guidelinesExcellent verbal and written communication skills in EnglishKnowledge of FDA, EMA, and ICH guidelines.Deep understanding of the drug development process and prior experience in the biopharmaceutical industry.
Please send resumes to mia@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!
specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a
Medical Writer
to work for a leading Greater Los Angeles area biotechnology company.
Salary:
$100-150/hr. depending on experienceOn-site or Remote1099 Contract2+ months contract w/ high chance of extension
Summary:The Medical Writer will be responsible for the preparation of high-quality regulatory documents, including clinical study reports, clinical summaries and overviews, study protocols, Investigator’s brochures, and informed consent forms. The Medical Writer may also be responsible for planning, managing, and preparing internal and external communications of key scientific and clinical data, including abstracts, poster and oral presentations, manuscripts, congress materials, and educational/training materials..
Responsibilities:Write, edit, and finalize CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents.Write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents.Write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients.Work collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documents.Lead document review meetings and discussions.Provide direction and solutions to cross-functional teams on expectations for document content.Perform QC of clinical and nonclinical documentsProvide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines.
Experience/Requirements:BS/BA in related life-science field required. (Master’s or PhD degree preferred)Experience in NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions.Strong scientific background in oncology, immunotherapy, or related fieldProficient knowledge of AMA writing guidelinesExcellent verbal and written communication skills in EnglishKnowledge of FDA, EMA, and ICH guidelines.Deep understanding of the drug development process and prior experience in the biopharmaceutical industry.
Please send resumes to mia@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!