Associate Director, Medical Writing
vor 1 Monat
Job Title: Associate 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.Position Summary:Reporting to the Senior Director, Medical Writing, the Associate Director, Medical Writing will be a key contributor to 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 the execution of medical writing deliverables.In collaboration with the Senior Director, Medical Writing, resource planning for medical writing needs across development programs, including the management of 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 support all aspects of key regulatory and clinical document production.Support clinical and regulatory document preparation (e.g., eCTD modules, briefing documents, study protocols, CSRs, IBs, and PIPs/PSPs), executing 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.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.Adhere to established 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; assist with procedure gap assessments.Apply 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:BA/BS degree with 8+ years or MS with 6+ 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 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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Associate Director, Medical Writing
vor 1 Monat
Brisbane, Österreich Vera Therapeutics, Inc VollzeitJob Title: Associate 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...
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Associate Director, Medical Writing
vor 1 Monat
Brisbane, Österreich Vera Therapeutics, Inc VollzeitJob Title: Associate 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...
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Associate Director, Medical Writing
vor 1 Monat
Brisbane, Österreich Vera Therapeutics, Inc VollzeitJob Title: Associate Director, Medical WritingLocation: 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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Brisbane, Österreich Tideri Jobbörse VollzeitJob Title: Associate 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...
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Senior Director, Medical Writing
vor 2 Monaten
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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Senior Director, Medical Writing
vor 2 Monaten
Brisbane, Österreich Vera Therapeutics, Inc VollzeitJob 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....
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Senior Director, Medical Writing
vor 2 Monaten
Brisbane, Österreich Tideri Jobbörse VollzeitJob 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...
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Associate Director, Quality Assurance
vor 2 Monaten
Brisbane, Österreich Vera Therapeutics, Inc VollzeitTitle: Associate Director, Quality Assurance – Medical Device/Combination ProductLocation: Brisbane, California About 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 in order to...
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Associate Director
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Associate Director, Quality Assurance
vor 2 Monaten
Brisbane, Österreich Vera Therapeutics, Inc VollzeitTitle: Associate Director, Quality Assurance – Medical Device/Combination Product Location: Brisbane, California About 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 in order to...
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Associate Director
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Associate Director, Change
vor 4 Wochen
Brisbane, Österreich Queensland University Of Technology VollzeitWe are seeking an Associate Director, Change to join the Administrative Division.As the Associate Director, Change, you will provide leadership and work with business areas to effectively design and implement organisational change. Leading a small team of change professionals, your role will be 'hands on' and you will be responsible for working with clients...
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Associate Director, Change
vor 3 Wochen
Brisbane, Österreich Queensland University Of Technology VollzeitWe are seeking an Associate Director, Change to join the Administrative Division.As the Associate Director, Change you will provide leadership and work with business areas to effectively design and implement organisational change. Leading a small team of change professionals, your role will be 'hands on' and you will be responsible for working with clients...
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Associate Director, Change
vor 4 Wochen
Brisbane, Österreich Queensland University Of Technology VollzeitWe are seeking an Associate Director, Change to join the Administrative Division.As the Associate Director, Change, you will provide leadership and work with business areas to effectively design and implement organisational change. Leading a small team of change professionals, your role will be 'hands on' and you will be responsible for working with clients...
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Brisbane, Österreich Tideri Jobbörse VollzeitAssociate Director of Academic and Career Development Founded in 1912, King's College is a thriving residential community for men and women within The University of Queensland servicing 354 undergraduate and postgraduate student residents and over 100 Associate Members.King's College has some of the best facilities of any residential college in Australia,...
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Brisbane, Österreich Tetra Tech VollzeitAssociate Director, Marketing and CommunicationsAre you a creative, self-driven marketing professional ready to make an impact in the international development sector?Do you excel at crafting high-quality, multi-media communications and collaborating with cross-functional teams to promote business growth?Join Tetra Tech International Development as our...
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Associate Director, Marketing And Communications
vor 16 Stunden
Brisbane, Österreich Tetra Tech VollzeitAssociate Director, Marketing and CommunicationsAre you a creative, self-driven marketing professional ready to make an impact in the international development sector?Do you excel at crafting high-quality, multi-media communications and collaborating with cross-functional teams to promote business growth?Join Tetra Tech International Development as our...
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Associate Director
vor 3 Wochen
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Associate Director
vor 3 Wochen
Brisbane, Österreich Adg Engineers (Aust) Pty Ltd VollzeitAbout ADG Engineers ADG Engineers is a national employee-owned engineering consultancy known for delivering innovative and sustainable solutions across Australia in civil and infrastructure, structures, and temporary works.As a consultancy, we pride ourselves on our commitment to technical excellence, client satisfaction, and fostering a collaborative work...
