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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
Job ID: 24003298-PHL600


Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We transform clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model places the customer and patient at the center of everything we do. We are always looking for ways to streamline our work and make Syneos Health a more collaborative and agile environment to help accelerate the delivery of therapies and change lives.

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


Why Syneos Health

  • Career Growth: We are passionate about developing our people through career progression, technical training, and peer recognition.

  • Culture: We embrace a Total Self culture where you can be your authentic self. This unified culture ensures our employees feel valued.

  • Diversity & Inclusion: We bring together diverse thoughts, backgrounds, and perspectives to create a workplace where everyone belongs.


Job Responsibilities

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

  • Project Leadership: Act as the lead for assigned writing projects, coordinating medical writing activities across departments.

  • Document Development: Develop and support various documents including:

    • Clinical study protocols, amendments, and reports

    • Patient narratives, clinical development plans

    • IND submissions, annual reports, NDA submissions

    • Investigator brochures, clinical journal manuscripts, and client presentations

  • Issue Resolution: Propose solutions to problems that arise during the writing process and escalate when necessary.

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

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

  • Regulatory Compliance: Ensure compliance with ICH-E3 guidelines and company SOPs while completing writing projects on time and within budget.

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

  • Budget Awareness: Work within project budgets and communicate changes to medical writing leadership.


Qualifications

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

  • Experience: Extensive medical writing experience with knowledge of FDA and ICH guidelines, and familiarity with AMA style guide.

  • Skills:

    • High proficiency in 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

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