Description
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.
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.
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.
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.