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Sr Medical Editor (Quality)

2+ years
Not Disclosed
10 Nov. 29, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Medical Editor

Company: Syneos Health
Location: [Location not specified]


About Syneos Health

Syneos Health is a leading biopharmaceutical solutions organization committed to accelerating customer success. With a workforce of 29,000 employees across 110 countries, Syneos Health specializes in integrating clinical, medical affairs, and commercial insights to drive impactful outcomes.

"Work Here Matters Everywhere"


Why Syneos Health?

Syneos Health fosters a culture of continuous growth, career progression, and a commitment to diversity and inclusivity. We prioritize developing our employees through training, mentorship, and peer recognition while providing a supportive work environment where individuals can bring their authentic selves to work.


Role Overview

As a Senior Medical Editor, you will lead editorial efforts for complex and large medical writing projects, ensuring that all documents meet regulatory requirements and adhere to high editorial standards. This role involves managing timelines, budgets, mentoring junior staff, and maintaining quality control of medical documents such as clinical reports and regulatory submissions.


Key Responsibilities

  • Editorial Leadership & Project Management:

    • Represent the editorial group in cross-functional study teams and project teams as needed.
    • Monitor project timelines and budgets, updating project managers or supervisors if deliverables are at risk.
    • Lead internal project-specific meetings and manage the editorial process for complex or large medical writing projects.
    • Manage multiple assignments, ensuring timely and accurate completion of tasks.
  • Copyediting & Quality Control:

    • Copyedit and proofread assigned documents, applying correct grammar, punctuation, and style per AMA or custom style guidelines.
    • Conduct data integrity reviews of documents to ensure accuracy and alignment with project requirements.
    • Contribute to the development of process improvement tools and revise internal policies and procedures for editorial work.
  • Mentorship & Training:

    • Train and mentor medical editors and writers on data integrity review, editorial standards, and best practices.
    • Provide technical support to medical writers, editors, and study teams as necessary.
    • Lead training sessions for the global Medical Writing team on various editorial topics.
  • Compliance & Industry Standards:

    • Stay informed about FDA, EU, ICH regulations, and other relevant industry standards to ensure compliance.
    • Help to ensure all editorial work adheres to company and client standards while meeting regulatory guidelines.
    • Assist in compiling and publishing medical writing deliverables when required.

Qualifications

Education & Experience:

  • Bachelor’s degree in Life Sciences, Clinical Sciences, English, Journalism, or a related field, or relevant publishing experience.
  • Extensive publishing experience, including proficiency with Adobe Acrobat, ISIToolbox, or other markup languages.
  • Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
  • Experience in data integrity review, copyediting, and document management is highly preferred.
  • Familiarity with AMA style guide and editorial standards for medical writing.
  • Experience with FDA, EU, ICH, and ISO standards is highly desirable.

Skills & Competencies:

  • Attention to detail, with strong organizational and project management skills.
  • Ability to work both independently and as part of a team while keeping stakeholders informed of progress.
  • Excellent grammatical and communication skills (both written and oral).
  • Ability to mentor and train other medical writers and editors.
  • Adaptable to changes in duties, responsibilities, and requirements.
  • Knowledge of regulatory requirements for medical writing is preferred.

Why Work with Us?

  • Career Development: Syneos Health is committed to fostering your professional growth through continuous training and mentorship.
  • Inclusive Culture: We believe in diversity and inclusion, encouraging employees from all backgrounds to contribute their perspectives and ideas.
  • Global Impact: As a part of Syneos Health, you'll contribute to developing innovative therapies that make a difference in patient outcomes worldwide.

Apply Now to join Syneos Health and make a difference in the world of medical writing and editing.


Syneos Health is an equal opportunity employer committed to creating a diverse and inclusive workplace. We encourage applicants from all backgrounds to apply and value transferable skills. Join our Talent Network to stay connected to additional career opportunities.