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Sr Medical Writer

0-2 years
Not Disclosed
10 May 2, 2025
Job Description
Job Type: Remote 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

 

Job Title: Senior Medical Writer

Location: Home-Based, Australia
Job ID: 24003298


Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. We are focused on addressing modern market realities by placing the customer and patient at the center of everything we do.

Our model is continuously evolving to simplify and streamline our work to make Syneos Health easier to collaborate with. Whether in a Functional Service Provider partnership or Full-Service environment, you’ll work alongside passionate problem solvers who innovate as a team to help customers achieve their goals.

Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE


Why Syneos Health

  • Career Development: Passionate about developing our people with career progression, technical and therapeutic area training, and recognition.

  • Inclusive Culture: We are committed to our Total Self culture, where you can authentically be yourself and be part of a team that brings diverse perspectives.

  • Diversity of Thought: Syneos Health embraces the richness that diversity brings to the workplace, creating an environment where everyone feels like they belong.


Job Responsibilities

  • Mentorship: Mentor and lead less experienced medical writers on complex projects.

  • Project Leadership: Manage medical writing activities associated with individual studies with minimal supervision.

  • Document Creation: Develop and support documents including:

    • Clinical study protocols and amendments

    • Clinical study reports

    • Patient narratives, clinical development plans

    • IND submissions, annual reports, NDA submissions

    • Investigator brochures, clinical journal manuscripts, and client presentations

  • Issue Resolution: Identify issues during the writing process and propose solutions, escalating when necessary.

  • Review Process: Review statistical analysis plans, tables, and figures for accuracy and consistency.

  • Collaboration: Work closely with data management, biostatistics, regulatory affairs, and medical affairs teams.

  • Regulatory Compliance: Ensure adherence to ICH-E3 guidelines and regulatory standards for all writing projects.

  • Literature Search: Conduct online clinical literature searches as required.

  • Budget Management: Work within the assigned project budget and communicate any changes to leadership.


Qualifications

  • Education: Bachelor of Science or Arts degree (preferably in Social Sciences, English, or Communications) with relevant scientific/medical knowledge.

  • Experience: Extensive experience in medical writing with a strong understanding of FDA and ICH regulations, and familiarity with the AMA style guide.

  • Skills:

    • High proficiency in Word, Excel, PowerPoint, email, and internet.

    • Strong leadership, proofreading, interpersonal, and presentation skills.

    • Ability to interpret and present complex clinical research data.


Additional Information

  • Travel: Minimal travel required (less than 25%).

  • Flexibility: Duties may evolve as needed by the company.

  • Equal Opportunity: Syneos Health is committed to ADA compliance and providing reasonable accommodations when necessary.


Impact & Achievements

Syneos Health has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000+ trial patients over the past five years.