Medical Writer (m/w/d)

Arbeitsagentur; Stein; Hybrid; EUR 55.000 - 70.000; Vollzeit

Benefits dieser Stelle

Hybrid options

Career development

Continuing education support

Zusammenfassung

Artivion is seeking a Medical Writer to draft and manage regulatory and clinical documents, including CERs, CEPs, and PMCF plans. You will collaborate with Clinical, R&D, QA/Regulatory, and Marketing to ensure alignment with current scientific literature and regulatory standards.

The role requires 2-4 years of experience in clinical or medical writing, strong English skills, and proficiency in literature research and data analysis.

Qualifikationen

• 2-4 years of relevant professional experience in clinical or medical writing.
• Strong organizational skills and attention to detail.
• Ability to interpret and explain scientific data from various sources including studies, literature, and technical documentation
• Excellent command of written and spoken English
• Proficiency in medical literature research, data analysis, and content development
• Experience collaborating with cross-functional teams such as Clinical, R&D, Quality, and Regulatory Affairs
• Experience with EU MDR (Medical Device Regulation), including familiarity with CERs, CEPs, PMCF plans, and other clinical evidence documents is an advantage

Aufgaben

• Draft, edit, and manage clinical documents such as CERs, CEPs, PMCF Plans, scientific articles and others
• Collaborate under supervision on moderately complex projects or support senior medical writers
• Coordinate document timelines and ensure timely delivery
• Conduct literature searches and appraisals in alignment with clinical and regulatory needs
• Assist in aligning documentation with risk/benefit assessments, current scientific literature, and regulatory standards
• Support meetings and communication related to clinical content and investigator materials
• Work closely with internal stakeholders (Clinical, R&D, RA/QA, Marketing) and external partners (surgeons, consultants, CROs)

Kenntnisse

Clinical writing

Regulatory knowledge

Scientific data interpretation

Literature research

English proficiency

Cross-functional collaboration

Data analysis

Content development

EU MDR familiarity

Jobbeschreibung

It’s a good feeling to know you're doing your best with purpose every day.At Artivion, we manufacture high-quality products and solutions for the treatment of aortic diseases. Together with surgeons worldwide, we save lives. In doing so, we rely on the strengths of each and every employee. Your strength counts, too: As an important link in the chain, you make a contribution to saving lives together with us. Contribute your strengths and let us grow together.

Medical Writer (m/f/d)

Location: Hechingen, Germany or Remote (Europe)

Your Strength

• 2-4 years of relevant professional experience in clinical or medical writing
• Strong organizational skills and attention to detail
• Ability to interpret and explain scientific data from various sources including studies, literature, and technical documentation
• Excellent command of written and spoken English
• Proficiency in medical literature research, data analysis, and content development
• Experience collaborating with cross-functional teams such as Clinical, R&D, Quality, and Regulatory Affairs
• Experience with EU MDR (Medical Device Regulation), including familiarity with Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Post-Market Clinical Follow-up (PMCF) plans, and other clinical evidence documents is an advantage

Your Contribution

• Draft, edit, proofread, and manage clinical documents such as CERs, CEPs, PMCF Plans, scientific articles and others
• Collaborate under supervision on moderately complex projects or support senior medical writers
• Coordinate document timelines and ensure timely delivery
• Conduct literature searches and appraisals in alignment with clinical and regulatory needs
• Assist in aligning documentation with risk/benefit assessments, current scientific literature, and regulatory standards
• Support meetings and communication related to clinical content and investigator materials
• Work closely with internal stakeholders (Clinical, R&D, RA/QA, Marketing) and external partners (surgeons, consultants, CROs)

Our Strength

• A mission-driven, international work environment focused on innovation and quality
• Exciting projects with a global impact in the medical device industry
• Career development opportunities, including training programs and support for continuing education
• Flexible working models, including hybrid options
• Attractive benefits including pension schemes, EGYM Wellpass, and more