25 km
Head of Medical Writing (m­­/­­f­­/­­d) 06.10.2024 JOTEC GmbH Hechingen
Weitere passende Anzeigen:

Ihre Merkliste/

Mit Klick auf einen Stern in der Trefferliste können Sie sich die Anzeige merken

1

Passende Jobs zu Ihrer Suche ...

... immer aktuell und kostenlos per E-Mail.
Sie können den Suchauftrag jederzeit abbestellen.
Es gilt unsere Datenschutzerklärung. Sie erhalten passende Angebote per E-Mail. Sie können sich jederzeit wieder kostenlos abmelden.

Informationen zur Anzeige:

Head of Medical Writing (m/f/d)
Hechingen
Aktualität: 06.10.2024

Anzeigeninhalt:

06.10.2024, JOTEC GmbH
Hechingen
Head of Medical Writing (m/f/d)
Aufgaben:
Establish medical and regulatory writing best practices (templates, SOPs, work instructions, document review, document timelines) to ensure consistency and quality of documents Lead writing team to ensure the generation of key documents in internal clinical partnerships with relevant functions (Project Management, Data Management and CRAs) on schedule and the support of key documents in Artivion partnerships with relevant functions (Regulatory Affairs, Quality, R&D and Sales & Marketing) Strategic and timely completion of key documents such as clinical study protocols, clinical study reports, responses to information requests from regulatory agencies, and major regulatory submissions Support MDR submissions on time with the accurate completion of CERs, and other post market activities Coordinate document writing, review, and revision to ensure the highest quality in conformity with program strategy and objectives Proactively plan future deliverables to ensure organizational alignment and preparation for document reviews in an efficient manner Oversight of medical and regulatory writing vendors in alignment with global internal resources, methods, SOPs, and overall approach
Qualifikationen:
Degree in medicine or natural science Long-standing years of experience as a medical writer in the medical / biomedical industry with evidence of increasing responsibility and technical development Proficient at writing protocols, manuscripts and study reports Aptitude for compilation, analysis, and presentation of data Ability to communicate fluently and effectively, both in writing and verbally Knowledge of ICH and GCP guidelines and any other regulations relevant to medical writing Competency to effectively manage and motivate teams to achieve corporate, departmental and program goals on time Efficiency in managing and motivating direct reports to maximize writers' contributions and career development Familiarity with medical devices, MDD and MDR Accomplished use of MS Word, PowerPoint and Adobe Acrobat Proficiency in written and spoken English Practice in managing medical writers preferred

Berufsfeld

Bundesland

Standorte