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Director of Scientific/Medical Writing

vor 3 Monaten


Mainz, Deutschland AL Solutions Vollzeit

Leading Immunotherapy Company Seeks Director of Scientific/Medical Writing

A global leader in immunotherapies and vaccines is seeking a Director of Scientific/Medical Writing to join their dynamic team in Mainz, Germany.

About the Company: This innovative biotechnology company is at the forefront of the immunotherapy revolution, developing novel therapies for cancer and other serious diseases. Their groundbreaking mRNA technology has proven transformative in the fight against COVID-19, and they continue to push boundaries in oncology and infectious diseases.

Position: Director of Scientific/Medical Writing Location: Mainz, Germany (minimum 2 days per week in office, hybrid work model)

Key Responsibilities:

  • Lead and manage a team of two medical writers, providing mentorship, guidance, and career development
  • Oversee the production of high-quality regulatory and scientific documents, including clinical study protocols, clinical study reports, investigator brochures, and regulatory submissions
  • Actively contribute to hands-on regulatory writing, particularly for MAA and NDA submissions
  • Ensure adherence to regulatory guidelines, company SOPs, and quality standards
  • Collaborate with cross-functional teams including clinical development, regulatory affairs, and biostatistics
  • Develop and implement best practices in medical writing and document management
  • Represent the medical writing function in key strategic discussions and initiatives

Requirements

  • Advanced degree (PhD or equivalent) in a scientific or medical field
  • Minimum of 8 years of experience in medical writing, with at least 3 years in a leadership role
  • Extensive experience in oncology writing; experience in vaccines or infectious diseases is a plus
  • Proven track record in regulatory writing, particularly MAA and NDA submissions
  • Strong understanding of drug development processes, ICH guidelines, and regulatory requirements
  • Excellent leadership, communication, and project management skills
  • Fluency in English; German language skills are advantageous

Benefits

Why Join This Company?

  • Be part of a company at the forefront of medical innovation
  • Work on groundbreaking therapies that are changing patients' lives
  • Collaborative and dynamic work environment
  • Opportunities for professional growth and development
  • Competitive compensation and benefits package

What They Offer:

  • Competitive salary commensurate with experience
  • Performance-based bonus and equity participation programs
  • Comprehensive health and retirement benefits
  • Flexible working hours and hybrid work model
  • Continuous learning and development opportunities
  • On-site amenities including cafeteria and fitness center

Join this innovative company and be part of their mission to harness the power of the immune system to develop and deliver novel therapies to patients. Apply now to contribute your expertise to their world-class scientific and medical writing team