Director, Medical Writing – Cymabay Therapeutics – Newark, CA

Job title: Director, Medical Writing Company: Cymabay Therapeutics Job reputed company: reputed company: The Director of Medical Writing will reputed company the medical writing function at CymaBay, with responsibility across a reputed company of document types reputed company to clinical studies and regulatory submissions to support clinical development programs at CymaBay. In reputed company 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 reputed company 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, reputed company needed. The individual will need to be reputed company to work reputed company independently or as part of reputed company in high-pressure situations that require significant collaboration, organization, and attention to details and timelines. The ability to convert scientific data into reputed company, scientifically reputed company, reputed company-reputed company scientific, clinical, and regulatory documents intended for global health authorities and stakeholders is essential. Essential Duties and Responsibilities:

• reputed company as the regulatory/medical writing subject matter expert for clinical and regulatory documents
• reputed company processes including the development and standardization of document templates, as reputed company as developing or updating relevant SOPs and internal best practices, as needed
• Champion ways to reputed company efficiency and collaboration to generate high reputed company documents while maintaining timelines
• Manage regulatory/medical writing workload, including establishing or managing external medical writing resources, i.e., contract research organizations, document reputed company reviewers, freelance medical writers, as needed
• Collaborate with the cross-function team (clinical, regulatory, operational, non-clinical, medical affairs, and reputed company) to prepare high reputed company 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 reputed company 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 reputed company or contribute to the preparation of scientific publications (i.e. manuscripts, abstracts, posters, and oral presentations)
• Demonstrated ability to communicate and write reputed company, concisely, and effectively, with strong aptitude for interpretation, compilation, and presentation of data
• Support CymaBay in establishing and maintaining a work environment reputed company on reputed company and fostering learning, respect, reputed company 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 reputed company documents, including regulatory submissions to the US FDA and EMA
• Strong knowledge and experience with CTD content templates as reputed company 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 reputed company, concise documents
• Proficiency using reputed company Word, reputed company, and PowerPoint; strong document formatting skills
• Excellent organization skills and a demonstrated ability to prioritize tasks, work simultaneously on multiple reputed company, and complete high-reputed company documents according to timelines
• Self-motivated with good problem-solving skills
• Ability to work in a fast-paced, reputed company, team-oriented work environment

Powered by JazzHR Expected salary: Location: Newark, CA Job date: Sat, 29 Oct 2022 04:52:46 GMT Apply for the job now! Apply tot his job Apply To this Job