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THThermo Fisher Scientific

Principal Medical Writer(m/w/x)

Karlsruhe
VollzeitRemoteSenior

Medical and scientific document creation for life-changing therapies. Managing complex projects and guiding junior writers required. Flexible working culture, award-winning learning and development.

Anforderungen

  • Bachelor's degree in scientific discipline or equivalent qualification
  • Advanced degree preferred
  • Experience providing knowledge, skills, and abilities for job (comparable to 8+ years)
  • Experience managing and directing complex medical writing projects required
  • Experience in pharmaceutical/CRO industry preferred
  • Submissions document experience advantageous
  • Experience in Neurosciences advantageous
  • Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
  • Significant knowledge of document development guidelines
  • In-depth knowledge in specialty areas
  • Excellent data interpretation skills
  • Excellent medical writing skills
  • Excellent grammatical skills
  • Excellent editorial skills
  • Excellent proofreading skills
  • Excellent project management skills
  • Advanced interpersonal communication skills
  • Advanced oral communication skills
  • Advanced written communication skills
  • Advanced presentation skills
  • Excellent negotiation skills
  • Excellent judgment
  • High independence in decision making
  • High independence in problem solving
  • Ability to mentor junior staff
  • Ability to lead junior staff

Aufgaben

  • Provide high-quality medical and scientific writing
  • Plan and coordinate document creation
  • Deliver final drafts to internal and external clients
  • Review documents for the team
  • Train and guide junior team members
  • Advise on document development strategy
  • Comply with regulations and industry best practices
  • Collaborate with internal and external clients
  • Research, write, and edit clinical study reports
  • Summarize data from clinical studies
  • Serve as primary author for complex documents
  • Write and provide input on IBs, INDs, and MAAs
  • Review routine and complex documents
  • Train and mentor writers and program managers
  • Ensure compliance with quality processes
  • Develop and review best practices and methods
  • Lead process improvement initiatives
  • Develop, review, and manage performance metrics
  • Represent the department at project meetings

Berufserfahrung

  • 8 Jahre

Ausbildung

  • Abgeschlossene BerufsausbildungODER
  • Bachelor-AbschlussODER
  • Master-Abschluss

Sprachen

  • Englischverhandlungssicher

Benefits

Weiterbildungsangebote

  • Award-winning learning and development programme

Flexibles Arbeiten

  • Flexible working culture
  • Work-life balance
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Thermo Fisher Scientific erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.

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