Senior Project Manager Scientific and Regulatory Medical Writing Ophthalmology (f/m/d)

Senior Project Manager Scientific and Regulatory Medical Writing Ophthalmology(f/m/d)

Join our team and make a difference in the world of ophthalmology!

targomed has been a trusted partner in the field of medical writing and clinical studies for over a decade. We are now seeking a passionate and experienced Senior Project Manager Scientific and Regulatory Medical Writing Ophthalmology (f/m/d) to join our team.

Your Responsibilities:

• Manage, supervise and coordinate scientific and regulatory medical writing projects in the field of medical devices in ophthalmology
• Interpretation of Data: Interpret clinical outcomes in ophthalmology.
• Scientific Medical Writing: Prepare and write articles with medical content for publication in English in peerreviewed and trade journals. Coordinate and revise the work of external medical writers
• Regulatory Document Creation: Write and manage regulatory documents under the EU MDR 2017/745, including Clinical Investigation Reports, Clinical Evaluation Reports, Clinical Evaluation Plans, PMCF Plans, SSCP, PSUR, etc.
• Data Analysis: Conduct statistical analyses and data evaluations in R (or similar platform) and MS Excel. Interpret outcomes of statistical analysis.
• Medical Content Creation: Create medical-scientific texts for brochures, websites, and presentations.
• Literature Search: Maintain a strong understanding of the available academic literature and conduct thorough literature searches.
• Client Communication: Foster strong relationships with clients and maintain open communication.

Your Qualifications:

• Educational Background: Degree in medicine, natural sciences, or a related field with a focus on ophthalmology.
• Experience: Proven experience in scientific and regulatory medical writing within the ophthalmology field.
• Statistical Skills: Strong background in statistics / biostatistics (degree in biostatistics is a plus) and proven experience in performing data analysis / statistical analysis in ‘R’ (or similar platform) and professional use of MS Excel.
• Soft Skills: Motivated, open-minded, communicative, and committed to delivering high-quality work.
• Organizational Skills: Ability to manage multiple projects simultaneously and prioritize tasks effectively.
• Regulatory Knowledge: Deep understanding of Medical Device Regulations (EU MDR 2017/745), especially in relation to the evaluation and reporting of clinical data.
• Language Skills: Excellent written and spoken English is essential; German is a plus.

What We offer:

• Diverse and Stimulating Environment: Work in a dynamic and collaborative team.
• Flexible Work Arrangements: Enjoy flexible working hours and the option to work remote.
• Supportive Culture: Benefit from a supportive and team-oriented work environment.
• Professional Growth: Opportunities to implement ideas and contribute to the team’s success.
• Open and Appreciative Collaboration: We value open communication and recognize the contributions of our team members.
• Full-Time or Part-Time Options (min. 20h): Choose the employment arrangement that best suits your needs.

Join our team and make a meaningful impact in the world of ophthalmology!
Please send your detailed application, including your expected salary, to

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