Medical Writer Lead

hace 4 semanas

Madrid, Madrid, España www.linkedincompany11408925 A tiempo completo
Job Title: Principal Medical Writer

At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. We are seeking a highly skilled Principal Medical Writer to join our team.

Job Summary:

The Principal Medical Writer will be responsible for mentoring and leading less experienced medical writers on complex projects, representing the Medical Writing department on clinical study teams, and advising clients and study teams on data presentation and production strategies.

Key Responsibilities:
  • Mentor and lead less experienced medical writers on complex projects
  • Represent the Medical Writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding a writing project
  • Advise clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained
  • Develop good working relationships with internal and external colleagues
  • Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
  • Develop or support a variety of documents, including clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, and annual reports
  • Review statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency
  • Serve as a peer reviewer, providing review comments to give maximum clarity of meaning, accuracy, relevance, and to ensure that client objectives are met and overall quality standards are maintained
  • Adhere to established regulatory standards, including ICH-E3 guidelines, as well as company SOPs, client standards, and company and/or client-approved templates when completing medical writing projects, on-time and on-budget
  • Perform online clinical literature searches, as applicable
  • Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills
  • Understand budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership
  • Complete required administrative tasks within the specified timeframes
Requirements:
  • Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English, or Communications, preferred) with relevant scientific and/or medical knowledge and expertise
  • Extensive knowledge of English grammar with a familiarity with AMA style guide
  • Understanding of FDA and ICH regulations and guidelines strongly preferred
  • Demonstrated effective presentation, proofreading, and interpersonal skills and ensure a team-oriented approach
  • Strong proficiency in Word, Excel, PowerPoint, email, and Internet
  • Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information
About Syneos Health:

Syneos Health is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Together, we share insights, use the latest technologies, and apply advanced business practices to speed our customers' delivery of important therapies to patients.

We support a diverse, equitable, and inclusive culture. Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability, or any other legally protected status.

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