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.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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