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Annexon
South San Francisco, CA, United States
Position Summary The Senior Director, Medical and Scientific Writing plays a critical role. Reporting to the SVP, Regulatory, Quality and Pharmacovigilance, you will work in partnership with a talented and collaborative team across our Research/Pre-Clinical, CMC, Regulatory, Clinical, and Quality organizations to author and drive development of key
Job Source: AnnexonMirum Pharmaceuticals
Foster City, CA, United States
Are you within a commutable distance to Foster City and willing to commit to a hybrid work schedule with being on site 2 days per week? * -- If you are not local to the Foster City area, are you willing to relocate? * Yes No I am local Are you currently authorized to work for any employer in the US without visa support? * -- By participating in
Job Source: Mirum PharmaceuticalsMeet
Menlo Park, CA, United States
Director, Medical and Regulatory Writing *Hybrid Role - Menlo Park, CA*' Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Director of Medical/Regulatory Writing to join their t
Job Source: MeetCorcept Therapeutics
Menlo Park, CA, United States
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercor
Job Source: Corcept TherapeuticsBeiGene
San Mateo, CA, United States
**General Description:** **Responsible for leading clinical regulatory medical writing activities for BeiGene that conform to domestic and/or international regulatory submission and internal document standards. Clinical regulatory documents include, but are not limited to, clinical study reports, clinical study protocols or amendments, investigator
Job Source: BeiGeneBeiGene
San Mateo, CA, United States
**General Description:** **Responsible for leading clinical regulatory medical writing activities for BeiGene that conform to domestic and/or international regulatory submission and internal document standards. Clinical regulatory documents include, but are not limited to, clinical study reports, clinical study protocols or amendments, investigator
Job Source: BeiGeneCorcept Therapeutics
Menlo Park, CA, United States
The Associate Director, Medical Writing (Regulatory) will collaborate with colleagues to write high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements. Responsibilities: Autho
Job Source: Corcept TherapeuticsThe Trade Desk
San Jose, CA, United States
The Trade Desk is changing the way global brands and their agencies advertise to audiences around the world. How? With a media buying platform that helps brands deliver a more insightful and relevant ad experience for consumersand sets a new standard for global reach, accuracy, and transparency. We are proud of the culture we have built. We value t
Job Source: The Trade DeskMenlo Park, CA, United States
The Senior Manager, Medical Writing will collaborate with colleagues to write high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements.
Responsibilities:
Author, co-author, critically edit, and format clinical/regulatory documents, including New Drug Applications (NDAs), protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, administrative letters, and other regulatory submissions as needed
Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Project Management, CMC, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents
Develop and manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs
Oversee vendors and contractors as necessary
Facilitate comment resolution and adjudication with authors, reviewers, and project teams
May serve as the functional area representative on project teams and advise such teams on content, format, and style requirements for documents
Participate in the development/refinement of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables
Assist in the interviewing, mentoring, and integration of medical writing staff as needed
Maintain subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines
Perform miscellaneous job-related duties and additional duties and responsibilities as needed
Preferred Skills, Qualifications and Technical Proficiencies:
Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines
Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness
Successful track record of working on complex clinical/regulatory writing projects across multiple therapeutic areas
Excellent attention to detail, multitasking, prioritization, and flexibility
Excellent communication skills with proven ability to interact in a cross-functional environment
Understanding of the drug-development process, including research and development processes and objectives and the required documents
Familiarity with US and European regulatory requirements and guidelines for documents; general knowledge of electronic Common Technical Document (e-CTD) requirements with respect to structure, format, and content
Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
Proficiency in use of MS Office applications (Word, Outlook, Excel, PowerPoint), Adobe Acrobat, electronic document management systems (eg, Veeva Vault), and templates (eg, StartingPoint)
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities
Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision
Ability to think strategically, be resourceful, and lead without formal authority
Preferred Education and Experience:
BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
5+ years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience writing clinical study protocols, clinical study reports, investigator’s brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs; Integrated Summary of Safety/Integrated Summary of Efficacy [ISS/ISE]); and understanding of the content of higher-level summary documents
Knowledge of endocrinology, oncology, neurology and/or metabolic disease areas preferred
The pay range that the Company reasonably expects to pay for this headquarters-based position is $181,000 - $213,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
If you are based in California, we encourage you to read this important information for California residents linked here.
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Email Alert for Senior Manager, Medical Writing jobs in Menlo Park, CA, United States
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