Job title: Director, Medical Writing
Company: Cymabay Therapeutics
Job description: Summary:
The Director of Medical Writing will lead the medical writing function at CymaBay, with responsibility across a range of document types related to clinical studies and regulatory submissions to support clinical development programs at CymaBay. In addition to serving as a leadership role to build the medical writing function, this position is responsible for authoring and managing the review and approval of moderately and highly and complex regulatory and clinical documents including but not limited to regulatory briefing documents, investigator brochures, clinical study reports, protocols, and sections of the Common Technical Document (CTD). This role will manage and liaise with contracted writing organizations but also directly author documents, when needed. The individual will need to be able to work well independently or as part of a team in high-pressure situations that require significant collaboration, organization, and attention to details and timelines. The ability to convert scientific data into clear, scientifically sound, well-structured scientific, clinical, and regulatory documents intended for global health authorities and stakeholders is essential.
Essential Duties and Responsibilities:
• Act as the regulatory/medical writing subject matter expert for clinical and regulatory documents
• Develop processes including the development and standardization of document templates, as well as developing or updating relevant SOPs and internal best practices, as needed
• Champion ways to achieve efficiency and collaboration to generate high quality documents while maintaining timelines
• Manage regulatory/medical writing workload, including establishing or managing external medical writing resources, i.e., contract research organizations, document quality reviewers, freelance medical writers, as needed
• Collaborate with the cross-function team (clinical, regulatory, operational, non-clinical, medical affairs, and commercial) to prepare high quality documents under strict timelines; documents may include clinical study protocols/amendments, clinical study reports, scientific advice briefing documents, investigator brochures, safety updates, orphan designation requests, Module 2 clinical summaries and the Clinical Overview for INDs and marketing applications, and regulatory responses
• Work closely with functional leadership and cross-functional project leads to ensure effective document prioritization and development
• May oversee or contribute to the preparation of scientific publications (i.e. manuscripts, abstracts, posters, and oral presentations)
• Demonstrated ability to communicate and write clearly, concisely, and effectively, with strong aptitude for interpretation, compilation, and presentation of data
• Support CymaBay in establishing and maintaining a work environment focused on quality and fostering learning, respect, open communication, collaboration, integration, and teamwork
Minimum Qualifications/Skills/Abilities:
• Minimum of BS/BA degree in science (Masters, PhD, or PharmD preferred) with 4+ years of relevant regulatory writing experience in the pharmaceutical and biotechnology industry
• 3+ years of experience leading teams and/or managing people (i.e. employees, contractors) desired for leadership positions
• Demonstrated experience in preparing clinical study protocols, study reports, investigator brochures, and eCTD clinical summary documents, including regulatory submissions to the US FDA and EMA
• Strong knowledge and experience with CTD content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation
• Knowledgeable of GCP, GXP requirements and FDA/EMA guidelines
• Strong attention to detail
• Excellent writing skills and an ability to generate clear, concise documents
• Proficiency using Microsoft Word, Excel, and PowerPoint; strong document formatting skills
• Excellent organization skills and a demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines
• Self-motivated with good problem-solving skills
• Ability to work in a fast-paced, collaborative, team-oriented work environment
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Expected salary:
Location: Newark, CA
Job date: Sat, 29 Oct 2022 04:52:46 GMT
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