Nonclinical Writer at Astellas in South San Francisco, California

Job Description:

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.

The Role:

In this role as a nonclinical writer in Astellas Gene Therapy (AGT) group, you will perform nonclinical study writing tasks of high complexity and regulatory impact supporting regulatory submissions, communications and data report writing. Additional tasks may include supporting the Bioanalytical team and producing method and analysis reports. You will be the specialist for the Integrative Biology team for interpreting data, transcribing methods, results, and driving discussions with stakeholders. Experience in writing gene therapy nonclinical documents such as pre-IND briefing documents, nonclinical sections of an IND/BLA/IB and other regulatory documents is highly desirable.

Responsibilities:

Primary role - Performing nonclinical writing tasks, such as:

• 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).

Acting as the Specialist & Subject Matter Expert in nonclinical writing within AGT:

• 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:

-Represent nonclinical Reporting in on-going improvements in cross-functional and global collaborations and sharing of better practices and knowledge.

-Maintain good working relationships with stakeholders and colleagues.

Secondary support of Bioanalytical group through method and analysis reports:

• 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.