Senior Medical Writer: Regulatory Submissions Lead

Syneos Health, Inc.; Belgique; 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 and manage regulatory submission documents across clinical studies. This role requires 3-5 years of experience in medical writing within the biopharmaceutical sector, and a strong understanding of FDA and ICH regulations. You will ensure high quality in documentation while collaborating with various departments. The position offers a competitive salary range of $80,600 to $145,000, depending on qualifications.

Prestations

Company car or car allowance

Medical, dental and vision benefits

401(k) company match

Employee Stock Purchase Plan

Flexible paid time off

Qualifications

• 3–5 years of relevant experience in medical writing.
• Experience in biopharmaceutical or contract research organizations required.
• Strong understanding of FDA and ICH regulations.

Responsabilités

• Lead completion of medical writing deliverables accurately.
• Complete various documents like clinical study protocols and reports.
• Coordinate quality reviews and act as a peer reviewer.

Connaissances

Presentation skills

Proofreading

Collaboration

Interpersonal skills

Project management

Time management

MS Office proficiency

Medical terminology understanding

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 and manage regulatory submission documents across clinical studies. This role requires 3-5 years of experience in medical writing within the biopharmaceutical sector, and a strong understanding of FDA and ICH regulations. You will ensure high quality in documentation while collaborating with various departments. The position offers a competitive salary range of $80,600 to $145,000, depending on qualifications.