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Position Summary
As a CMC Technical Authoring Lead, you are positioned in the CMC Program Management Department. You are responsible for managing and executing the preparation of CMC documents for regulatory submissions. Working together closely with the CMC Regulatory Department, you will support building regulatory strategies for HOOKIPA’s pipeline programs. You will have a crucial part in establishing HOOKIPA’s arenavirus platform by ensuring consistent information in all submission documents. Building a knowledge base for HOOKIPA’s Drug Master File will be one of your key activities. You are responsible for providing submission ready documents according to the program timelines. You compile information for CMC sections of regulatory submissions out of source documentation and author those sections. By identifying the necessary source documents and advising SMEs on content requirements for those documents, you will help to build a strong foundation for our submissions. A strong background in biotechnology and excellent writing skills, as well as an ability to work in a fast-paced environment in a cross-functional team are essential behaviors for this role. Furthermore, excellent knowledge of applicable guidelines and experience in writing documents for regulatory submissions is necessary.
- Identify supporting documents required for submissions and negotiate the delivery of technical source documents in accordance with program timelines
- Define CMC content requirements for regulatory submissions and review this content for conformance with established requirement
- Apply a comprehensive understanding of global RA CMC regulations and guidelines to write high quality submission ready documents that enhance probability of regulatory success and ensure regulatory compliance
- Plan regulatory submissions as well as life cycle activities for assigned programs in close cooperation with the regulatory department
- Manage and execute the preparation of CMC documents for regulatory submissions as well as life cycle activities for assigned programs
- Author selected critical source documents for marketing authorization applications
- Highlight anticipated and ongoing critical issues arising through the program life-cycle in a timely manner
- Collaborate with internal partners on implementing strategies, ensuring timelines and compliance
- Ensure and/or enhance regulatory compliance with respect to filing requirements
- Contribute to the preparation of CMC risk analysis
Qualifications
- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent. Advanced degree is desirable.
- A minimum of three years of experience in the pharmaceutical industry
- A minimum of two years of experience in writing submission-ready documents for CMC sections of regulatory submissions. More experience is desirable.
- Experience in preparation of CMC sections for regulatory submissions in the field of oncology, vaccines or biologics is preferable
- Experience in preparation of BLA / MAA filings is a plus
- Excellent knowledge of relevant guidelines
- Excellent interpersonal skills with the ability to act as a liaison with other departments
- Excellent organization and planning skills
- Self-motivated with a great sense of ownership in the area of responsibility
- Great time-management, ability to perform very well under time pressure
- Ability to work with a cross-functional team
- Fluent in English, both spoken and written
- Valid EU working permit
What we offer
- Strong team with dedicated and passionate employees
- State of the art infrastructure
- An excellent working atmosphere
- Opportunities for personal development
- Employee benefits such as health screening, public transportation card, Sodexo pass
- Working in a multinational and multicultural environment
We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 4.112,- based on fulltime (40 hours per week); depending on experience and qualification salary can be negotiated. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.
Starting date: as soon as possible
Contact:
If you (m/f/d) are interested in this challenging position, please send your CV including a cover letter (summarizing your qualification and experiences) as well as your credentials to: talent@hookipapharma.com
For more information on HOOKIPA please visit www.hookipapharma.com
