Nonclinical Writer
Astellas Pharma
- San Francisco, CA
- $132,000-176,000 per year
- Permanent
- Full-time
- Drafting nonclinical sections of: Internal governance documents, pre-investigational new drug applications (pIND), IND and Investigator brochures (IBs).
- Nonclinical summary and overview documents in CTD/eCTD format for regulatory submissions world-wide (including investigational medicinal product dossiers (IMPDs), (INDs), marketing authorization applications (MAAs), biologics license application (BLA), new drug applications (NDAs), and others.
- Deliverables (briefing book, slides) for Advisory Committee Meetings.
- Publications (abstracts, posters and slide presentations for conferences and other scientific meetings, and manuscripts for scientific journals).
- Other ad-hoc documents (e.g., meeting packages, nonclinical part of Astellas internal documents).
- Work closely with pharmacology, toxicology, study management and regulatory group to elaborate on nonclinical sections of the regulatory documents.
- Maintain knowledge and competencies within gene therapy and biologics field.
- Be updated on relevant guidelines and other external requirements in the therapeutic area.
- Establishing new and improved methods within field of expertise.
- Act as primary stakeholder contact concerning project-specific nonclinical writing issues.
- Reach out to relevant key stakeholders to identify the need, timing and scoping of MW documents.
- Represent nonclinical writing in relevant project groups.
- Prioritize and delegate tasks within the project.
- Contributing to knowledge sharing, skill building and good collaboration with stakeholders and colleagues:
- Collaborating with Bioanalytical Scientists within Integrative Biology through drafting method and analysis reports.
- Experience writing bioanalytical reports for molecular and immunological assays such as PCR and ELISA.
- Experienced in reviewing data in various formats and adapting data to fit specified templates.
- Master’s degree with relevant experience; PhD degree preferred.
- 5 years’ experience as nonclinical writer or equivalent.
- Experience in writing biologics, preferred AAV gene therapy related nonclinical/regulatory documents.
- Experience in working in pharmaceutical industry.
- Excellent understanding of nonclinical development and regulatory processes and requirements.
- Excellent communication and presentation skills.
- Experience with a broad range of different medical writing tasks.
- Established record of being a proactive team-player and able to deliver on time and with high quality.
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Referral bonus program