Role summaryexecutive director, medical writing responsible for establishing and managing the cardiorenal medical writing group within bridgebio, overseeing development and finalization of clinical and regulatory documents, and guiding internal and external medical writers to deliver high-quality submissions and disclosures in regulatory programs.responsibilitiesoversee the cardiorenal medical writing group, including leading, training, and mentoring for effective performancelead medical writing from concept to final product for clinical study protocols, amendments, csrs, investigator brochures, and related documentsprovide strategic leadership to study teams for preparation of protocols, csrs, submissions, and public disclosure documentslead medical writing for regulatory submissions including inds, nda/maa data modules, briefing documents, and related documentation for marketing authorization or label expansiondemonstrate in-depth knowledge of regulatory writing and data disclosure requirementsensure sops related to document development conform with regulatory requirements and guide teams through these processespartner with clinical development, biostatistics, and data management in reviewing data presentations and narrative planningwork with study teams to ensure results in clinical documents accurately reflect dataproject manage the document review process, resolving conflicts and addressing comments in a timely mannerensure documents are submission-ready and archived in the document management systemperform quality control checks on deliverables, respond to findings, and implement quality improvementsestablish medical writing support models and implement strategies to improve efficiency and productivity; oversee vendor management as neededqualificationspost-graduate scientific or medical degree (e.g., ms, mph, phd, pharmd, md, do) with 10+ years of regulatory medical writing experience in biotech/pharmaceuticalsexperience in medical writing for multiple regulatory filings at various development stagesexperience managing consultants and their projectsexcellent oral and written communication skills with the ability to summarize complex scientific data clearlyproficient in drug development processes with strong understanding of health authority regulations and ich guidelinesstrong interpersonal, listening, and influencing skillsstrong project management skills; able to work independently, multi-task, and perform under pressureexperience with endnote, startingpoint templates, and veeva vault is preferredskillsstrategic leadership in medical writingregulatory writing and data disclosure proficiencycross-functional collaboration with clinical development, biostatistics, and data managementdocument development standards, sops, and quality control processesvendor management and process improvements
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