Precision Life Sciences
Medical Writer
Precision Life Sciences, Boston, Massachusetts, us, 02298
Job Title: Medical WriterPRINCIPLE DUTIES:
Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.
Write, edit, and finalize NDA, IND, CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documentsAs needed, write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documentsWrite effectively for diverse audiences, including scientists, physicians, payers, regulators, and patientsWork collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documentsLead document review meetings and discussionsProvide direction and solutions to cross-functional teams on expectations for document contentPerform QC of clinical and nonclinical documentsProvide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelinesParticipate in project team meetingsQUALIFICATIONS/EXPERIENCE:
Minimum of Bachelor’s degree in science (Masters or Ph.D. preferred)Experience in IND and/or NDA submissions and writing CSRs, IBs, clinical study protocols, and other documents for regulatory submissionsA minimum of 5 years in Medical Writing with experience of marketing application submissions (NDAs and MAAs, associated pivotal CSRs) is preferred.Strong scientific background in rheumatology, endocrinology, metabolic disease, or related field
KEY COMPETENCIES:
Excellent 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 particularly in preparing the NDA.Excellent time- and project management skills, attention to detail, and ability to balance multiple projects simultaneouslyStrong critical and logical thinking with the ability to analyze problems, identify alternative solutions, and implement recommendations for resolutionAbility to work collaboratively in a dynamic environmentHighly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote, and eCTD authoring templates
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Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.
Write, edit, and finalize NDA, IND, CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documentsAs needed, write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documentsWrite effectively for diverse audiences, including scientists, physicians, payers, regulators, and patientsWork collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documentsLead document review meetings and discussionsProvide direction and solutions to cross-functional teams on expectations for document contentPerform QC of clinical and nonclinical documentsProvide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelinesParticipate in project team meetingsQUALIFICATIONS/EXPERIENCE:
Minimum of Bachelor’s degree in science (Masters or Ph.D. preferred)Experience in IND and/or NDA submissions and writing CSRs, IBs, clinical study protocols, and other documents for regulatory submissionsA minimum of 5 years in Medical Writing with experience of marketing application submissions (NDAs and MAAs, associated pivotal CSRs) is preferred.Strong scientific background in rheumatology, endocrinology, metabolic disease, or related field
KEY COMPETENCIES:
Excellent 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 particularly in preparing the NDA.Excellent time- and project management skills, attention to detail, and ability to balance multiple projects simultaneouslyStrong critical and logical thinking with the ability to analyze problems, identify alternative solutions, and implement recommendations for resolutionAbility to work collaboratively in a dynamic environmentHighly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote, and eCTD authoring templates
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