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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Associate Director, Clinical Regulatory Affairs
South San Francisco, CA 94083 US
Posted: 11/05/2024
2024-11-05
2024-12-13
Employment Type:
Direct Hire
Job Category: Regulatory
Job Number: 3879
Job Description
Associate Director, Clinical Regulatory Affairs
We are seeking an Associate Director who will provide leadership in development and execution of document deliverables intended to support clinical trial applications including Health Authority interactions and filings, such as briefing documents, INDs/ CTAs, and marketing applications. This successful candidate will be proficient in the principles of scientific writing and will work cross?functionally, advising the team on regulatory expectations for document content while maintaining compliance with global (FDA, EMA, ICH) regulatory expectations for document content. Experience in oncology drug development is strongly preferred.
Responsibilities:
We are seeking an Associate Director who will provide leadership in development and execution of document deliverables intended to support clinical trial applications including Health Authority interactions and filings, such as briefing documents, INDs/ CTAs, and marketing applications. This successful candidate will be proficient in the principles of scientific writing and will work cross?functionally, advising the team on regulatory expectations for document content while maintaining compliance with global (FDA, EMA, ICH) regulatory expectations for document content. Experience in oncology drug development is strongly preferred.
Responsibilities:
- Collaborates with Medical functions on authoring of documents intended to support clinical trials including (but not limited to) protocols, investigator brochure’s, clinical study reports, clinical summaries for marketing applications, and responses to queries from regulatory authorities.
- Leads the preparation, review, and planning of submissions to global health authorities to support the initiation, maintenance, and closure of clinical studies.
- Leads meeting strategy, preparations for and participates in meetings with regulatory agencies.
- Independently authors complex documents compliant with relevant internal processes and standards as well as external regulatory guidance.
- Collaborates cross-functionally with subject matter experts to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
- Engages early with project teams and subject matter experts to plan and review tables, listings, and figures for assigned documents.
- Works with Project Management and Regulatory Affairs functions to establish appropriate timelines and identify contingencies for delivery of assigned documents in a timely manner.
- Perform internal document reviews, editing, and QC as needed.
- BS/BA, MS/MA or PhD with a minimum of 5 years of experience in regulatory/clinical writing.
- Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
- Experience with independently authoring CSRs, protocols and submission documents, such as IND components
- Ability to manage documents of greater complexity and/or variety.
- Collaborative project management skills; demonstrated ability to prioritize multiple projects and timelines.
- Strong analytical skills; ability to understand and interpret complex clinical and scientific data and formulate those data into a well-thought out and reviewer friendly manner.
- Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
- how to cite such information appropriately.
- Able to consolidate, analyze, interpret, and summarize data from multiple data sources.
- Capable of leading discussions of benefit/risk assessment and regulatory impact of documents and analyses, with minimal guidance.
- Track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences.
- Demonstrated proficiency with Microsoft Word (above average knowledge) and other relevant software (eg, PowerPoint, Excel, Adobe Acrobat).
- Strong attention to detail; experience with Quality Control and editing of scientific documents.
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