Head of Medical Writing Ophthalmology (f/m/d) (Medical Writer)

Stellenbeschreibung

 
Head of 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 Head of Medical Writing Ophthalmology (f/m/d) to join our team.

Your Responsibilities:

- Lead, coordinate and develop the Medical Writing team
- Manage, supervise and coordinate scientific and regulatory medical writing projects in the field of
medical devices in ophthalmology.
- Prepare and review articles with predominantly medical content for publication in English (peer-review and trade journals)
- Create and review regulatory documents under the scope of EU MDR 2017/745 (e.g. Clinical Investigation Reports, Clinical Evaluation Reports, Clinical Evaluation Plans, PMCF Plans, SSCP, PSUR, etc.)
- Ensure the highest quality and scientific accuracy in all medical writing deliverables.
- Collaborate with interdisciplinary teams to ensure the quality and consistency of medical content
- Support data analysis in collaboration with Data Manager and Biostatistician.
- Assess and interpret clinical outcomes in Ophthalmology.
- Maintain a strong understanding of Good Clinical Practice and relevant regulatory guidelines.

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. At least 6 years of experience in Medical Writing, preferably in Ophthalmology
- Experience in team and project leadership
- Excellent written and verbal communication skills
- Knowledge of regulatory requirements and guidelines (e.g., ICH-GCP)
- Ability to collaborate in an interdisciplinary team
- 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. 30h): 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 <a href="mailto:[email protected]" rel="nofollow">[email protected]</a>.

targomed GmbH
Gerald Erbe
Amalienstraße 2
76646 Bruchsal
<a href="mailto:[email protected]" rel="nofollow">[email protected]</a>
<a href="http://www.targomed.de" target="_blank" rel="nofollow">www.targomed.de</a>


Ergänzende Informationen:
Anforderungen an den Bewerber: 
Erweiterte Kenntnisse: Augenoptik, Regulatory Affairs (Medizintechnik), Augenheilkunde (ärztlich)
Expertenkenntnisse: Medical Writing, Gruppen-, Teamleitung