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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: Mandaluyong-Ortigas-Centre, Philippines (Home-Based)
Job ID: 24003298-PHL600


Company Overview

Syneos Health® is a fully 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.

Our Clinical Development model brings the customer and the patient to the center of everything we do. We continuously look for ways to simplify and streamline our work, making Syneos Health easier to work with and easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

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 through career progression, technical training, and peer recognition.

  • Culture: Committed to a Total Self culture where you can authentically be yourself.

  • Diversity & Inclusion: We embrace diverse thoughts, backgrounds, and perspectives, creating a place where everyone feels they belong.


Job Responsibilities

  • Mentorship: Lead and mentor less experienced medical writers on complex projects.

  • Project Management: Lead medical writing activities, coordinating within and across departments with minimal supervision.

  • Document Creation: Develop or support a variety of documents including:

    • Clinical study protocols, amendments, and reports

    • Patient narratives, clinical development plans

    • IND submissions, annual reports, NDA submissions

    • Investigator brochures, clinical journal manuscripts, client presentations

  • Problem-Solving: Identify and propose solutions to issues arising during the writing process.

  • Review: Ensure content accuracy by reviewing statistical analysis plans, tables, and figures for grammar, format, and consistency.

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

  • Regulatory Compliance: Adhere to ICH-E3 guidelines and company SOPs while completing projects on time and within budget.

  • Literature Research: Perform online clinical literature searches as applicable.

  • Budget Management: Work within project budgets 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: Significant medical writing experience with knowledge of FDA and ICH guidelines and AMA style guide.

  • Skills:

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

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

    • Ability to interpret and present clinical research data effectively.


Additional Information

  • Travel: Minimal (less than 25%).

  • Job Flexibility: The company may assign other tasks as necessary.

  • Equal Opportunity: Syneos Health is committed to compliance with the ADA and Equal Opportunity employment laws.


Impact & Achievements

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