Specialist Medical Writing & Advice (m/f/x)

Wörwag Pharma; Böblingen; Vor Ort; EUR 45.000 - 70.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Specialist in Medical Writing and Advice to join their dynamic team in Böblingen. This role involves preparing eCTD dossiers for marketing authorizations and ensuring compliance with regulatory standards. You'll collaborate with various departments to maintain high-quality documentation and support regulatory inquiries. The company offers a vibrant international environment with opportunities for personal and professional growth, competitive compensation, and attractive benefits tailored to enhance work-life balance. If you are passionate about medical writing and regulatory affairs, this is the perfect opportunity for you.

Leistungen

Flexible working hours

Health-promoting measures

Bonago vouchers

Mobility allowances

Opportunities for professional development

Qualifikationen

• Completed scientific studies or comparable education.
• Several years of experience in Medical Affairs or Regulatory Affairs.

Aufgaben

• Preparation of eCTD dossiers for marketing authorizations.
• Review of clinical and non-clinical documents for accuracy.
• Support of Regulatory Affairs and Global Pharmacovigilance.

Kenntnisse

Medical Writing

Regulatory Affairs

Analytical Skills

German (C1 Level)

English

Ausbildung

Master’s in Pharmaceutical Sciences

Master’s in Medical Sciences

Engineering

Jobbeschreibung

Wörwag Pharma – a medium-sized, internationally active, family-owned pharmaceutical company headquartered in Böblingen near Stuttgart, Germany, which recognized and scientifically proved the importance of biofactors very early on. For more than 50 years, we have been fighting the civilization diseases of our time - preventive, accompanying, healing. Our slogan "Getting closer helping better" is not just a promise to doctors, pharmacists, and patients. It is an expression of our colorful corporate culture and our collegial cooperation among our now 1,200 employees worldwide.

Become a part of our team at our headquarters in Böblingen (near Stuttgart) because we are looking for you as a

Specialist Medical Writing and Advice (m / w / d)

These tasks await you

1. Preparation of parts of eCTD dossiers relevant for marketing authorizations in compliance with regulatory and internal specifications for European and global markets.
2. Review and evaluation of the accuracy, consistency, and plausibility of externally produced clinical and non-clinical documents relevant for marketing authorization.
3. Review and evaluation of information texts for medicinal products and food supplements.
4. Support of Regulatory Affairs and Global Pharmacovigilance in medical/scientific issues.
5. Editing/review of technical information and directions for use, focusing on medico-scientific content, including originator adjustments and review of SmPC and PIL for the Biofactors portfolio, especially for Deficiency Letter responses in German.
6. Collaborate with the manager of the Generic portfolio to complete the Originator Adaptation process and maintain up-to-date, compliant Generics PILs and SmPCs.
7. Serve as a contact person for regulatory authorities and internal clients regarding non-clinical and clinical dossier questions.
8. Ensure compliance with internal deadlines and quality standards for the above processes.

What you bring with you

1. Successfully completed scientific studies or a comparable scientific education (e.g., Master’s, Pharmaceutical sciences, Medical sciences, Engineering).
2. Several years of professional experience in Medical Affairs (Medical Writing) and/or Regulatory Affairs/Regulatory Medical Writing is advantageous.
3. Strong ability to produce high-quality written documents and verify the technical accuracy of externally produced documents.
4. Ability to work both independently and in a team, with accuracy and goal orientation.
5. Analytical and structured thinking and working style.
6. Excellent communication and assertiveness skills, proficiency in German (native or C1 level) and very good English skills.

We offer you

• A dynamic, international environment with quick responsibility assignment, opportunity to contribute expertise, and implement ideas.
• Varied challenges and exciting projects with a strong team spirit.
• Market-competitive compensation based on performance, with additional benefits tailored to your needs, such as:

Subsidies and Benefits

• Individual options for days off, pension provisions, or payouts.
• Bonago vouchers for special occasions.
• Support for your well-being and work-life balance.
• Health-promoting measures, including discounts on OTC pharmacy products and health days.
• Flexible trust working hours (24 hours/week) and up to 75% remote work.
• Central location with good public transport links and mobility allowances.
• Opportunities for personal and professional development.