- 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, clinical study reports, IND/NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
- Strong project management and team facilitation skills to lead complex projects in a fast-paced matrix environment
- Ability to influence without authority and foster the productive exchange of ideas amongst colleagues
- Experience managing projects of increasing scope and complexity.
- Experience managing direct reports and/or contractors
- Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcomes).
- Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment and competing priorities
- Highly effective communication skills and the ability to present ideas and data clearly to a group, including key stakeholders at a senior level.
- Familiarity with approaches to expedite document preparation such as review tools and automation
Preferred Qualifications: - Master's or doctorate degree in life sciences; oncology experience strongly preferred
- Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective solutions.
- High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
$218,978 - $274,868 a year
The salary range for this position at the Director level is between $218,978 and $238,725. The salary range is an estimate and may vary based on the Company's compensation practices.
The salary range for this position at the Senior Director level is between $255,150 and $274,868. The salary range is an estimate and may vary based on the Company's compensation practices.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company's facilities, with partial work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Benefits
Along with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs. All full-time employees will also be eligible for an annual bonus and equity refresh.
IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.
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Director/Senior Director, Medical Writing - South San Francisco, United States - IDEAYA Biosciences
Description
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
Position Summary:
We are 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.
What you'll do:
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