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Director/Senior Director, Medical Writing
IDEAYA BiosciencesSouth San Francisco, United Statesfull_timeVerifiedPosted 19 Oct 2024
💰 $278,598/yr($218,800/yr – $278,598/yr)
About the role
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We are applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality – which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has an industry leading platform and pipeline in precision medicine / synthetic lethality. IDEAYA wholly-owns or controls its three most-advanced clinical programs. It has established strategic collaborations with GSK, Amgen, Pfizer and Gilead supporting certain clinical and preclinical pipeline programs. When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.
Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com
Position Summary:IDEAYA is seeking a highly motivated, well-organized, and skilled Director or Sr Director of Medical Writing to lead cross-functional teams in content preparation for submission to regulatory authorities; partners closely with key stakeholders, applies critical thinking, scientific writing, data interpretation, and knowledge of regulatory content life cycle.Position level will be commensurate with experience.This role is based in either South San Francisco or San Diego, California, with an expectation to be in office 4 days a week.Local candidate applications only please. Relocation assistance will not be provided for this role.
Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com
Position Summary:IDEAYA is seeking a highly motivated, well-organized, and skilled Director or Sr Director of Medical Writing to lead cross-functional teams in content preparation for submission to regulatory authorities; partners closely with key stakeholders, applies critical thinking, scientific writing, data interpretation, and knowledge of regulatory content life cycle.Position level will be commensurate with experience.This role is based in either South San Francisco or San Diego, California, with an expectation to be in office 4 days a week.Local candidate applications only please. Relocation assistance will not be provided for this role.
What you'll do:
- Lead the preparation of clinical and regulatory documents (e.g. Protocols, Investigator Brochures, IND Reports, Briefing Documents) in accordance with applicable guidelines, IDEAYA standards/SOPs and content management principles
- Plan content in partnership with functional leads and create timelines for the production of assigned documents.
- Responsible for planning, managing, and aligning medical writing activities and communication across multiple projects and development programs
- Responsible for organization, clarity, scientific standards, formatting and consistency of content within and across all documents for a product or within a clinical dossier.
- Lead document adjudication meetings and resolve issues with cross-functional contributors.
- Manage the review and approval process, including liaising with development partners
- Serve as publishing point of contact
- Work effectively with cross-functional, geographically and culturally diverse teams and establish strong collaborative relationships by creating an atmosphere of openness and trust.
Requirements:
- Bachelor’s degree in life sciences
- Minimum of 8-10 years of relevant experience in biotech/pharmaceutical industry with at least 5 years of direct medical writing experience
- Demonstrated ability to produce clear, high-quality writing in the English language AND demonstrated experience in the preparation of a broad range of complex clinical and regulatory documents and global submissions
- Experience with the planning, authoring, review, and approval of clinical and regulatory documents including, but not limited to protocols, clinica
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