Senior Manager - Clinical/Medical Writer – Regulatory Affairs (m/f/d)

Position Summary

HOOKIPA Pharma Inc has an immediate opening for a clinical/medical writer position. The Clinical/Medical Writer will join the Regulatory Affairs team to develop high-quality, scientifically accurate documents in accordance with international government regulations and guidelines to support regulatory submission for Hookipa’s clinical trial applications and trial conduct. 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. As Clinical/Medical Writer, you will ideally have a background in at least one of the following scientific areas: molecular biology, virology, gene therapy, tumor biology, immunology, or related fields. The ideal candidate is a clear and precise detail-oriented writer with strong scientific knowledge, driven, independent, and able to respond quickly to evolving needs. Good analytical and writing skills, ability to work in a fast-paced environment, and professionalism are all essential behaviors for this role. 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.

• Authors, reviews and edits clinical and regulatory documents (clinical trial protocols and amendments; Investigator’s Brochures [IBs])
• Coordinates the development of cross-functional documents (GMO applications for genetically engineered microorganisms; original IBs; response documents to regulatory competent authorities)
• 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

• 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:
If you 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