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Medical Writer Ii (Clinical Trial Transparency)

0-2 years
Not Disclosed
10 April 22, 2025
Job Description
Job Type: Full Time 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

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.