Regulatory Affairs Associate Director (Medical Writer)

Proclinical is seeking a Medical Regulatory Associate Director - Medical Writer who is passionate about radiopharmaceuticals and has a strong background in medical writing. This role is pivotal in ensuring compliance with European regulations, maintaining clinical information, and supporting various medical functions. Fluency in French is a key requirement for this role.

Responsibilities:

• Draft clinical expert reports for European marketing authorizations (MA) and renewals.
• Interface with French and other competent authorities on medical issues.
• Regularly update clinical information on radiopharmaceuticals with respect to collected peer-reviewed data.
• Participate in the EU SPECT and PET LMR Committee.
• Provide medical support for pharmacovigilance activities.
• Serve as a permanent member of the signal detection group and the committee on good use of the medicine.
• Support the Medical Affairs and Information departments to source responses and up-to-date clinical communications.
• Collaborate with Marketing, Sales, and Manufacturing teams.
• Update CCDS for SPECT products and manage pharmacovigilance cases.

Key Skills and Requirements:

• PhD or PharmD is required for this role.
• Familiarity with European regulations governing the validation of SPCs, the construction of the clinical section of French marketing authorizations, and responses to questions from French agencies.
• Excellent medical French and English communication skills.
• Good knowledge of MS Office and databases.
• Ability to work independently as well as part of a team.
• Willingness to travel as required.

If you are having difficulty in applying or if you have any questions, please contact OpieInglis on o.inglis@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.