Global Medical Writer

Vor 5 Tagen

Wien, Österreich Octapharma Vollzeit

Stellen-ID: 55994- Standort: Wien, AT- Karrierestufe: Experte- Fachbereich: Forschung und Entwicklung- Beschäftigungstyp: Befristete Anstellung- Karrierestufe:
Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a successful research location of the Octapharma Group. Since our company continues to grow, we are looking for a **maternity leave replacement (until August 2025)**:
**Your new challenges which will inspire you**:

- Write, review and coordinate the preparation of documents under the responsibility of medical writing department
- Editorial and quality control review of documents prepared by external medical writers
- Ensure that all deliverables are provided on the appropriate milestone date
- Collaborate with other functions concerning safety issues relative to safety writing activities such as pharmacovigilance personnel, medical reviewers, clinical department, products quality, regulatory affairs and marketing
- Participate in ongoing safety data review and analysis for products in designated therapeutic areas
- Contribute to the review and development of existing and new SOPs and provide input or write/update and review SOPs
- Ensure archiving and traceability of all activities
- Maintain awareness of changes to/new regulations affecting Pharmacovigilance activities and Clinical Regulatory Documents
- Preparation and review of response documents to specific requests from regulatory/health au-thorities
- Registration of products & indications in EudraVigilace
- Disclosure of studies and results on Clinicaltrials.gov and EudraCT

**Your profile that will convince us**:

- Completed academic degree, ideally in a medical or healthcare discipline
- Experience in pharmacovigilance, medical writing and preparation of safety documents would be an advantage
- Very good verbal and written English skills as well as communication and presentation skills
- Team player with a strong focus on timelines
- Good level of computer literacy, in particular in the use of databases, MS Word and MS Excel
- High degree of accuracy with attention to detail
- Excellent critical, analytical and problem-solving skills

**Our attractive benefits for you**:

- Wide range of tasks in an international setting, flexibility and personal responsibility
- Reliable employer with generous employee benefits and a salary customary in the market.
- Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant, extraordinary staff events and many more:
**Additional Information**:
**The minimum gross salary according to the collective agreement (chemical industry) for your new job is EUR 3.909,67. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay salaries higher than collectively agreed.

We are looking forward to new, committed employees who join forces with us to promote our strong growth in order to keep enabling our patients to live a better life - because it is in our blood Is it in your blood too?

**Your contact**:
Mag. (FH) Charlotte Ponzer
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien
T: +43 (1) 610 32 - 1301

**Working at Octapharma**:
Whether your interests lie in the field of research and development, production, marketing, sales, finance or engineering, there are many career opportunities at Octapharma

We are the world's largest family-owned plasma company and entirely European. In the spirit of our founder Wolfgang Marguerre, we do not pursue short-term profit goals, but have future generations in mind. Our vision: we are passionate about developing new healthcare solutions that improve lives. We own 6 modern production facilities in Austria, France, Germany, Sweden and Mexico. The Marguerre family continues to play an essential role in the company's day-to-day operations.

Octapharma wants to offer its employees a working environment that challenges them as much as it enriches them. Since its foundation in 1983, the company has grown steadily and today we employ almost 10,000 people.

**Über Octapharma**:
Octapharma mit Hauptsitz in Lachen, Schweiz, ist einer der weltweit führenden Hersteller von menschlichen Proteinen. Das Unternehmen entwickelt und produziert Humanproteine aus Blutplasma und menschlichen Zelllinien.

Weltweit beschäftigt Octapharma mehr als 11.000 Mitarbeiter, die mit Produkten aus folgenden drei Therapiebereichen die Behandlung von Patienten in 118 Ländern unterstützen: Immuntherapie, Hämatologie und Intensivpflege.

Octapharma betreibt sieben Standorte Forschung & Entwicklung und fünf hochmoderne Produktionsanlagen in Österreich, Frankreich, Deutschland und Schweden, sowie mehr als 190 Plasmaspendezentren in Europa und den USA.

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