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

TN Germany; Böblingen; Vor Ort; EUR 45.000 - 70.000; Teilzeit

Zusammenfassung

Join a dynamic, family-owned pharmaceutical company as a Specialist in Medical Writing and Advice. You will play a vital role in preparing eCTD dossiers and ensuring compliance with regulatory standards. This position offers the opportunity to work in a collaborative environment, tackling exciting projects that contribute to public health. With a focus on personal and professional development, you'll enjoy flexible working hours and a supportive company culture. If you have a passion for medical writing and regulatory affairs, this is the perfect opportunity to make a meaningful impact.

Leistungen

Subsidy for direct insurance

Flexible options for days off

Bonago vouchers for special occasions

Health measures like discounts on OTC products

Support for work-life balance

Mobile work up to 75%

Opportunities for personal development

Qualifikationen

• Successfully completed scientific studies or comparable education.
• Several years of experience in Medical Affairs or Regulatory Affairs.
• Strong ability to produce high-quality written documents.

Aufgaben

• Prepare eCTD dossiers for marketing authorizations.
• Review clinical and non-clinical documents for accuracy.
• Interface with Regulatory Affairs on medical/scientific issues.

Kenntnisse

Medical Writing

Regulatory Affairs

Analytical Skills

Communication Skills

Teamwork

Ausbildung

Master in Pharmaceutical Sciences

Master in Medical Sciences

Engineering Degree

Jobbeschreibung

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Job Reference:

33074f193b5c

Job Views:

1

Posted:

05.05.2025

Expiry Date:

19.06.2025

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Job Description:

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 in 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

• Collaborate in preparing parts of eCTD dossiers relevant for marketing authorizations in accordance with regulatory and internal specifications for European and global markets.
• Review and evaluate the accuracy, consistency, and plausibility of externally produced clinical and non-clinical documents relevant for marketing authorization.
• Review and evaluate information texts for medicinal products and food supplements.
• Interface with and support Regulatory Affairs and Global Pharmacovigilance in medical/scientific issues.
• Edit/review technical information and directions for use, including medico-scientific passages, Originator adjustments, and review of SmPC and PIL for Deficiency Letter responses in German for the Biofactors portfolio.
• Collaborate with the manager of the Generic portfolio to complete the Originator Adaptation process and maintain the Generics PILs and SmPCs up-to-date and compliant.
• Serve as a contact person for regulatory authorities and internal customers regarding non-clinical and clinical questions on dossier parts.
• Ensure compliance with internal deadlines and quality standards for the above processes.

What you bring with you

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

We offer you

• A dynamic, international environment with opportunities for responsibility, contribution, and idea implementation.
• Varied challenges and exciting projects with a strong team spirit.
• Market-aligned compensation based on performance, plus additional benefits such as:
• Subsidy for direct insurance
• Flexible options for days off, pension, or payout
• Bonago vouchers for special occasions
• Support for well-being and work-life balance
• Health measures like discounts on OTC pharmacy products and health days
• Flexible trust working hours (24 hours/week) and the possibility of mobile work up to 75%.
• Central headquarters with good public transport connections and mobility allowances.
• Opportunities for personal and professional development.