Head of Medical Writing (m/f/d)

It's a good feeling to know you're doing your bestwith pur pose every day. At Arti vion, we manu facture high-qualityproducts and solu tions for the treat ment of aortic dis eases.

Together with sur geons world wide, we save lives. In doing so, werely on the strengths of each and every employee. Your strengthcounts, too : As an impor tant link in the chain, you make acontri bution to saving lives to gether with us.

Contribute yourstrengths and let us grow to gether. We are hiring HEAD OF MEDICALWRITING m / f / d Your strength : Degree in medicine or natural scienceLong-standing years of experience as a medical writer in themedical / biomedical industry with evidence of increasingresponsibility and technical development Proficient at writingprotocols, manuscripts and study reports Aptitude for compilation,analysis, and presentation of data Ability to communicate fluentlyand effectively, both in writing and verbally Knowledge of ICH andGCP guidelines and any other regulations relevant to medicalwriting Competency to effectively manage and motivate teams toachieve corporate, departmental and program goals on timeEfficiency in managing and motivating direct reports to maximizewriters' contributions and career development Familiarity withmedical devices, MDD and MDR Accomplished use of MS Word,PowerPoint and Adobe Acrobat Proficiency in written and spokenEnglish Practice in managing medical writers preferred Yourcontribution : Establish medical and regulatory writing bestpractices (templates, SOPs, work instructions, document review,document timelines) to ensure consistency and quality of documentsLead writing team to ensure the generation of key documents ininternal clinical partnerships with relevant functions (ProjectManagement, Data Management and CRAs) on schedule and the supportof 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 clinicalstudy protocols, clinical study reports, responses to informationrequests from regulatory agencies, and major regulatory submissionsSupport MDR submissions on time with the accurate completion ofCERs, and other post market activities Coordinate document writing,review, and revision to ensure the highest quality in conformitywith program strategy and objectives Proactively plan futuredeliverables to ensure organizational alignment and preparation fordocument reviews in an efficient manner Oversight of medical andregulatory writing vendors in alignment with global internalresources, methods, SOPs, and overall approach Our strength : Anexciting field of activity in a challenging clinical environment Anautonomous area of responsibility Active participation in aninternational clinical team Intensive training with mentoringprogram Diverse benefits such as mobile working, bike leasing andcompany pension Apply now and join the Artivion team.

We lookforward to hearing from you! Apply now! Daniel Weber,[email protected], T +49 (0)7471 922 353 JOTEC GmbH, awholly owned subsidiary of Artivion, Inc.

Lotzenäcker 23, 72379Hechingen, www.artivion.com