Instagram
youtube
Facebook

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, Philippines
Job ID: 24003298-PHL975


Company Overview

Syneos Health® is a leading 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 that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with but to make us 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 our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

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


Why Syneos Health

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

  • Culture: We are committed to our Total Self culture – where you can authentically be yourself.

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


Job Responsibilities

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

  • Project Leadership: Lead and manage medical writing activities for individual studies with minimal supervision.

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

    • Clinical study protocols, amendments, reports

    • Patient narratives, clinical development plans

    • IND submissions, annual reports, NDA submissions

    • Investigator brochures, clinical journal manuscripts, client presentations

  • Problem Resolution: Identify solutions to challenges during the writing process and escalate as needed.

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

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

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

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

  • Budget Awareness: Work within project budget specifications and communicate 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 experience in medical writing with knowledge of FDA and ICH guidelines and AMA style guide.

  • Skills:

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

    • 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 and responsibilities as needed.

  • 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.