Senior Manager

vor 1 Woche

Wien, Österreich HOOKIPA Biotech GmbH Vollzeit

**About HOOKIPA**:
HOOKIPA Pharma Inc. is a clinical stage biopharmaceutical company developing a new class of immunotherapeutics, targeting infectious diseases and cancers based on its proprietary arenavirus platform that is designed to reprogram the body’s immune system.

**Position Summary**:
As a Clinical/Medical Writer in Regulatory Affairs, you will work collaboratively with the R&D, Clinical and Technical Development teams to analyze data, author, review, edit, and submit, clinical, and regulatory documents to competent regulatory authorities.

This position within the Regulatory Affairs department offers a hybrid work environment (remote work possible with some in-office days required) and is to be based in Vienna, Austria or in New York, USA.

**Main Responsibilities**:

- Authors, reviews and edits clinical and regulatory documents (clinical trial protocols and amendments; Investigator’s Brochures [IBs])
- Participates in cross-functional teams,
- Participates in the analysis and interpretation of scientific and/or clinical data (e.g., responses to GMO regulatory authorities, clinical study reports)

**Qualifications & Skills**:

- 5+ years of experience in clinical/pharmaceutical development with directly related clinical/medical writing experience
- Advanced degree in a relevant scientific/clinical/regulatory field preferred; Master’s degree required (PhD preferred)
- Proven excellent verbal and written communication skills in English
- Strong interpersonal communication skills
- Excellent working knowledge of writing-related computer software, templates, project management (e.g., smartsheet) and reference management (e.g., Endnote) software and electronic document management systems
- Ability to analytically evaluate and interpret clinical and scientific data, possibly using science-related software’s (e.g., GraphPad Prism for data analysis, Lasergene suite for sequence analysis).
- Ability to work independently as well as within cross functional teams
- Strong project management skills including understanding of timelines (study and submission level), and ability to appropriately manage resources across multiple projects with competing workload priorities within a deadline-oriented fast-paced environment
- Global regulatory submission experience preferred

**What we offer**:

- Strong team with dedicated and passionate employees
- Environment that truly values scientific excellence, creativity and initiative
- An excellent working atmosphere
- Opportunities for personal development
- Working in a multinational and multicultural environment

Employee benefits such as health screening, public transportation card, Sodexo pass

We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 4.828, - 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**:

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