Associate Director Regulatory/Medical Writer
Clinical Development | Emeryville, CA | Full Time
Eureka Therapeutics is a privately-held biotechnology company focused on developing novel T cell-based immunotherapies for hematological malignancies and solid tumors. Our unique platform is aimed at developing safe and effective genetically engineered T cells against surface cancer antigens as well as TCR-mimic antibodies, which recognize previously inaccessible cancer antigens specific for solid tumors. We have built strong pipelines of innovative drugs, with the most advanced candidates in clinical stage. In addition to our internal drug discovery programs, Eureka has ongoing partnerships with several major pharma and academic centers of excellence. To learn more about us, please visit our website at www.eurekatherapeutics.com.
Eureka Therapeutics is currently looking for a Regulatory Writer with experience in regulatory operations. An advanced degree in medical/scientific sciences with a strong regulatory background is needed to develop all GCP documents and plans as well as regulatory documents and submissions (Expedited pathways, ODD, briefing documents, INDs, Clinical Study reports, NDAs and associated amendments). The Medical Writer reports to the CMO, supporting the Clinical and Regulatory programs.
- Manage, write, and edit clinical and regulatory documents, communications and publications for clinical programs in accordance with predefined timelines.
- Write, edit and facilitate the review of clinical study reports, investigator’s brochures, clinical data summaries, expedited pathways, ODD, briefing documents, INDs, clinical study reports, NDAs and associated amendments and other medical/regulatory documents. Develop and manage timelines, perform project management from document origination, internal and external reviews, QC, finalization and submission to appropriate regulatory agency.
- Work with clinical data manager and bio-statistician to develop reports on clinical studies. Evaluate draft documents and draft statistical output for accuracy and consistency. Develop and manage timelines.
- Preparation and write research publications such as abstracts, posters, PowerPoint presentations, manuscripts.
- Responsible for clinical trial registration and results disclosure in compliance with US and EU requirements.
- Develop standards and processes for clinical document production.
- Develop and manage clinical library/information systems.
- Other duties as assigned.
- A minimum of 5-7 years in clinical drug development; a minimum of 4 years in regulatory/medical writing.
- Masters or PhD degree in a life sciences or medical discipline.
- Proven ability to carry out regulatory submissions as stipulated in applicable regulations and guidelines for biologics and/or cellular therapies.
- Hands-on experience in:
- Writing, project managing, reviewing and submission of regulatory documents for US and global regulatory filings to include IB, CSR, ISS, ISE, Safety and efficacy narratives, GCP SOPs and plans, protocol, ICF, Safety reports, INDs, NDAs, and BLAs, expedited pathways applications and ODD. Prior regulatory submission experience preferred, including eCTD standards.
- Producing documents in oncology drug development.
- Managing external medical writers and vendors
- Project managing the document writing, review cycles and timelines and communicating with team members to maintain awareness of expectations, milestones, and deliverables.
- In-depth understanding of regulatory/ICH guidelines and GCPs, Good Publication Practices (GPP) and related standards (e.g. CONSORT, ICMJE), and clinical trial transparency requirements (e.g. EudraCT, clinicaltrials.gov).
- Critically analyze, synthesize, and present complex information in well-constructed documents.
- Expert abilities in Microsoft Office Suite, Adobe Acrobat, and electronic content management systems.
- Strong written and verbal communication skills with excellent attention to detail relative to consistency, grammar, syntax and scientific accuracy.
Personal and Leadership Competencies:
- Has a hands-on and time sensitive approach to projects
- Task-oriented view of work with a commitment to timelines and deliverables.
- Ability to manage multiple projects and adapt to changing priorities.
- Experiences working in a matrix environment within the clinical team and have strong influencing skills.
- Ability to apply knowledge and experience to new situations. Has the flexibility and willingness to solve problems that fall outside of immediate area of expertise.
- Experience in oncology therapeutic area preferred
- Excellent organizational, writing, communication, and time management skills.
- Work independently in an interdisciplinary, fast-paced, often changing environment.
- Detail-oriented, analytical, and ability to make independent decisions.
Please submit your resume or CV and cover letter on Jobscore. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
Eureka Therapeutics is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, religion, color, sex, age, ancestry, national origin, marital status, veteran status, medical conditions, handicap, physical or mental disability, sexual orientation, or any other status protected by law.
If you are a recruiter or placement agency, please do not submit resumes to any employees at Eureka Therapeutics, Inc. prior to having a signed agreement. Eureka Therapeutics is not liable for and will not pay agency fees for candidates submitted by any agency other than its approved recruitment partners. Furthermore, any resumes sent to us without an agreement in place will be considered your company’s gift to Eureka Therapeutics and may be forwarded to our recruiters for their attention.