Regulatory Medical Writer Team Lead

Há 5 dias

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

Company Overview

Syneos Health, Inc. is a leading biopharmaceutical solutions organization that accelerates customer success by translating unique clinical, medical affairs, and commercial insights into outcomes.

We are built to simplify and streamline our work, making Syneos Health easier to work with and for our employees.

Job Description

As a Principal/Sr Regulatory Medical Writer, you will mentor and lead less experienced medical writers on complex projects and act as a lead for assigned writing projects.

You will manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.

Responsibilities

  • Mentors and leads less experienced medical writers on complex projects, as necessary.
  • Acts as lead for assigned writing projects.
  • Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
  • Develops or supports a variety of documents, including clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, and annual reports.
  • Identifies and proposes solutions to resolve issues and questions arising during the writing process.
  • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency.
  • Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
  • Serves as peer reviewer on internal review teams, providing review comments on draft and final documents.
  • Adheres to established regulatory standards, including ICH-E3 guidelines, Company Standard Operating Procedures, client standards, and approved templates when completing medical writing projects.
  • Performs online clinical literature searches, as applicable.
  • Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.

Requirements

  • Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English, or Communications) with relevant scientific and/or medical knowledge and expertise.
  • Extensive knowledge of English grammar and FDA and ICH regulations and guidelines.
  • Familiarity with AMA style guide.
  • Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills.
  • Team-oriented approach.
  • Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
  • Ability to demonstrate a familiarity with principles of clinical research and interpret and present clinical data and other complex information.

Benefits

At Syneos Health, we offer a dynamic work environment, opportunities for career growth and development, and a total rewards program that includes competitive compensation and benefits.

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