Vera Therapeutics
Senior Director, Medical Writing
Vera Therapeutics, Brisbane, California, United States, 94005
Vera Therapeutics - Senior Director, Medical Writing
Location: Brisbane, CAAbout Us: Vera Therapeutics (Nasdaq: VERA) is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases to change the standard of care for patients.Position Summary: The Senior Director, Medical Writing will report to the SVP, Development Operations and will be responsible for overseeing medical writing activities for all of Vera's drug development programs, producing high-quality regulatory and clinical documents that meet regulatory and industry standards.Responsibilities:
Responsible for oversight of overall medical writing capabilities and deliverables.Plan and resource medical writing needs across development programs, including the management of in-house medical writers and medical writing vendors, as needed.Understand, critically analyze, and interpret data and summarize complex results in a clear, concise, and scientifically accurate manner.Work with functional representatives such as regulatory affairs, clinical and nonclinical development, clinical pharmacology, biometrics, program management, and other key personnel to manage all aspects of key regulatory and clinical document production.Lead all aspects of clinical and regulatory document preparation (e.g., eCTD modules, briefing documents, study protocols, CSRs, IBs, and PIPs/PSPs), leading writing strategy, driving document content and organization, and collaborating with project teams and subject matter experts on document development and reviews to ensure clear, accurate, and effective presentation of analyses and messaging.Develop and manage document timelines, ensuring alignment with overall regulatory and program timelines in coordination with regulatory affairs, project management, and cross-functional leadership.Communicate with project teams to maintain awareness of document expectations and deliverables.Develop processes and procedures to improve cross-functional workflows, establishing effective writing processes, style standards, reviewer guidelines, and quality control processes to ensure cross-document consistency and high-quality deliverables.Stay current with product regulatory guidance documents; assist with procedure gap assessments.Apply knowledge of relevant regulatory requirements and corporate policies to assess document requirements and identify information gaps or other potential issues.Detail-oriented, self-directed, collaborative, and flexible, with the ability to adapt and manage workload to meet project timelines.As needed, support scientific communication needs, such as abstracts, presentations, and manuscripts.Qualifications:
Minimum of BA/BS degree with 12+ years or MS with 10+ years medical writing experience in a CRO or pharma/biotech company, including experience preparing and managing documents for global regulatory submissions (e.g., INDs/NDAs/BLAs, briefing documents, PIPs/PSPs).Excellent written and verbal communication skills, including a demonstrated ability to effectively communicate within project teams and departments and among external collaborators.Ability to provide strategic input on document development across programs and drive operational efficiencies.Knowledge of US and international requirements and guidance associated with clinical and regulatory documents and scientific publications (e.g., ICH, AMA, ICMJE).Innovative, with problem-solving and peer-influence skills.Ability to operate in alignment with Vera's core values.Vera Therapeutics Inc. is an equal-opportunity employer. For this role, the anticipated base pay range begins at $268,000. The exact base pay offered will depend on various factors, including geography, qualifications, skills, and experience. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.
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Location: Brisbane, CAAbout Us: Vera Therapeutics (Nasdaq: VERA) is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases to change the standard of care for patients.Position Summary: The Senior Director, Medical Writing will report to the SVP, Development Operations and will be responsible for overseeing medical writing activities for all of Vera's drug development programs, producing high-quality regulatory and clinical documents that meet regulatory and industry standards.Responsibilities:
Responsible for oversight of overall medical writing capabilities and deliverables.Plan and resource medical writing needs across development programs, including the management of in-house medical writers and medical writing vendors, as needed.Understand, critically analyze, and interpret data and summarize complex results in a clear, concise, and scientifically accurate manner.Work with functional representatives such as regulatory affairs, clinical and nonclinical development, clinical pharmacology, biometrics, program management, and other key personnel to manage all aspects of key regulatory and clinical document production.Lead all aspects of clinical and regulatory document preparation (e.g., eCTD modules, briefing documents, study protocols, CSRs, IBs, and PIPs/PSPs), leading writing strategy, driving document content and organization, and collaborating with project teams and subject matter experts on document development and reviews to ensure clear, accurate, and effective presentation of analyses and messaging.Develop and manage document timelines, ensuring alignment with overall regulatory and program timelines in coordination with regulatory affairs, project management, and cross-functional leadership.Communicate with project teams to maintain awareness of document expectations and deliverables.Develop processes and procedures to improve cross-functional workflows, establishing effective writing processes, style standards, reviewer guidelines, and quality control processes to ensure cross-document consistency and high-quality deliverables.Stay current with product regulatory guidance documents; assist with procedure gap assessments.Apply knowledge of relevant regulatory requirements and corporate policies to assess document requirements and identify information gaps or other potential issues.Detail-oriented, self-directed, collaborative, and flexible, with the ability to adapt and manage workload to meet project timelines.As needed, support scientific communication needs, such as abstracts, presentations, and manuscripts.Qualifications:
Minimum of BA/BS degree with 12+ years or MS with 10+ years medical writing experience in a CRO or pharma/biotech company, including experience preparing and managing documents for global regulatory submissions (e.g., INDs/NDAs/BLAs, briefing documents, PIPs/PSPs).Excellent written and verbal communication skills, including a demonstrated ability to effectively communicate within project teams and departments and among external collaborators.Ability to provide strategic input on document development across programs and drive operational efficiencies.Knowledge of US and international requirements and guidance associated with clinical and regulatory documents and scientific publications (e.g., ICH, AMA, ICMJE).Innovative, with problem-solving and peer-influence skills.Ability to operate in alignment with Vera's core values.Vera Therapeutics Inc. is an equal-opportunity employer. For this role, the anticipated base pay range begins at $268,000. The exact base pay offered will depend on various factors, including geography, qualifications, skills, and experience. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.
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