Principal Medical Writer: Regulatory Submissions Lead

Syneos Health, Inc.; Montrouge; Sur place; EUR 68 000 - 124 000; Plein temps

Résumé du poste

A leading biopharmaceutical solutions organization is seeking a Principal Medical Writer to lead the creation of regulatory submission documents in Montrouge, France. The ideal candidate will have a Bachelor's degree and 3-5 years of relevant writing experience, with a strong grasp of FDA and ICH regulations. Responsibilities include managing medical writing activities across studies, ensuring clear documentation, and collaborating with various departments. This role offers a competitive salary ranging from $80,600 to $145,000 per year based on experience and qualifications.

Prestations

Health benefits including Medical, Dental and Vision

401k company match

Employee Stock Purchase Plan

Flexible paid time off

Qualifications

• 3-5 years of experience in science, technical, or medical writing.
• Experience in biopharmaceutical or contract research organization required.
• Strong understanding of FDA and ICH regulations.

Responsabilités

• Lead the completion of medical writing deliverables ensuring clarity and accuracy.
• Manage medical writing activities for individual studies across departments.
• Complete a variety of regulatory and clinical documents adhering to standards.

Connaissances

Strong presentation skills

Proofreading

Collaborative skills

Interpersonal skills

Time management

MS Office proficiency

Formation

Bachelor's degree in a relevant discipline

Graduate degree preferred

Description du poste

A leading biopharmaceutical solutions organization is seeking a Principal Medical Writer to lead the creation of regulatory submission documents in Montrouge, France. The ideal candidate will have a Bachelor's degree and 3-5 years of relevant writing experience, with a strong grasp of FDA and ICH regulations. Responsibilities include managing medical writing activities across studies, ensuring clear documentation, and collaborating with various departments. This role offers a competitive salary ranging from $80,600 to $145,000 per year based on experience and qualifications.