Senior Director, Medical Writing
vor 2 Wochen
Job Title: Senior Director, Medical Writing
Location: Brisbane, CA
About Us:
Vera Therapeutics (Nasdaq: VERA) is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.
Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.
Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis.
For more information please visit: .
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.
Ability to 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.
Stays current with product regulatory guidance documents; assists with procedure gap assessments.
Applies knowledge of relevant regulatory requirements and corporate policies as well as work experience to assess document requirements and identify information gaps or other potential issues.
Takes appropriate risks to resolve any identified 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.
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Senior Director, Medical Writing
vor 2 Wochen
Brisbane, Österreich Vera Therapeutics, Inc VollzeitJob Title: 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. Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients....
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