Medical Writer II (Clinical Trial Transparency):
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002559
Updated On: April 3, 2025
Company Overview:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, committed to accelerating customer success by translating clinical, medical affairs, and commercial insights into actionable outcomes. With a strong focus on bringing customers and patients to the center of our model, we streamline processes to create a collaborative and efficient environment.
Why Syneos Health:
Passionate about developing people through career progression, supportive management, technical training, and total rewards programs.
Embraces a "Total Self" culture fostering authenticity and belonging.
Continuously working toward creating a company employees and customers aspire to work with, by leveraging diversity of thoughts, backgrounds, and perspectives.
Job Responsibilities:
Mentor less experienced medical writers on assigned projects as needed.
Compile, write, and edit medical writing deliverables with minimal supervision.
Develop or support a variety of documents including:
Clinical study protocols and amendments
Clinical study reports
Patient narratives
Annual reports
Investigator brochures
Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams to produce high-quality deliverables.
Serve as a peer reviewer to ensure scientific content, clarity, consistency, and format adherence.
Maintain compliance with regulatory standards including ICH-E3 guidelines, company SOPs, client standards, and approved templates.
Conduct online clinical literature searches as applicable.
Demonstrate working knowledge of drug development processes and regulatory guidelines.
Engage in professional development activities to stay updated with regulatory and client expectations.
Manage assigned project budgets effectively, communicate budget deviations to leadership.
Complete administrative tasks within specified timeframes.
Perform additional related duties as assigned.
Minimal travel required (less than 25%).
Qualifications:
Bachelor of Science degree with relevant writing experience, or Bachelor of Arts degree (Social Sciences, English, or Communications preferred) with relevant scientific/medical knowledge.
Strong command of English grammar, FDA and ICH regulations, and familiarity with the AMA style guide.
Ability to work independently with effective presentation, proofreading, interpersonal, and leadership skills.
Proficient in Microsoft Word, Excel, PowerPoint, email, and internet navigation.
Familiarity with principles of clinical research and ability to interpret and present complex clinical data.
About Syneos Health:
Worked with 94% of all Novel FDA Approved Drugs over the past five years.
Collaborated on 95% of EMA Authorized Products.
Conducted over 200 studies across 73,000 sites with more than 675,000 trial patients.
Encourages employees to challenge the status quo in a competitive and ever-evolving environment.
Additional Information:
Job responsibilities may vary based on business needs.
Equivalent skills, experience, or education will be considered.
No employment contract is created by this job description.
Committed to ADA compliance and providing reasonable accommodations as appropriate.
Adheres to the EU Equality Directive and other applicable international legislations.
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