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Regulatory Medical Writer Lead

2 semanas atrás

Lisboa, Lisboa, Portugal Syneos Health, Inc. Tempo inteiro

**Job Overview**

Syneos Health, Inc. is a leading biopharmaceutical solutions organization accelerating customer success. We translate clinical, medical affairs, and commercial insights into outcomes addressing modern market realities.

**Job Description**

We are seeking an experienced Medical Writing Team Lead to join our team. As a key member of our medical writing department, you will lead complex projects and mentor less experienced medical writers. Your expertise will help develop and support various documents, including clinical study protocols, reports, patient narratives, and regulatory submissions.

**Responsibilities**

  • Mentor and lead less experienced medical writers on complex projects.
  • Act as the lead for assigned writing projects.
  • Manage medical writing activities associated with individual studies, coordinating across departments with minimal supervision.
  • Develop or support various documents, including clinical study protocols, reports, patient narratives, and regulatory submissions.
  • Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.

**Requirements**

  • Proven experience in medical writing, particularly in regulatory submissions.
  • Strong leadership skills, with the ability to mentor and guide team members.
  • Excellent communication and project management skills.
  • Familiarity with regulatory standards, including ICH-E3 guidelines.