Sr Medical Writer /Medical Writer 2 (Clinical Trial Transparency)

Syneos Health

2+ years

Not Disclosed

Gurugram

10 March 9, 2025

Job Description

Job Type: Full Time Education: BA/BS 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

Senior Medical Writer / Medical Writer 2 (Clinical Trial Transparency)
Updated: March 6, 2025
Location: India-Asia Pacific - IND-Gurugram-DLF Downtown, India
Job ID: 25001397-IND501

Description:

Senior Medical Writer

Join Syneos Health and be part of a growing and evolving biopharmaceutical industry leader. Our team of 25,000+ employees worldwide works to improve patients’ lives. At Syneos Health, we believe every patient is more than a number—they are family, friends, and neighbors.

Why Syneos Health?

Total Self Culture: We encourage authenticity and inclusivity, knowing that unique contributions make a difference.
Comprehensive Benefits: We offer total health coverage—physical, mental, and financial.
Diversity & Collaboration: We bring together diverse thoughts, backgrounds, and perspectives to create a workplace where everyone belongs.

Job Summary:

The Clinical Trial Disclosure team plays a crucial role in executing projects for Syneos global clients. The Senior Medical Writer processes complex scientific, medical, and technical information within high-performing teams.

Skills & Experience:

Experience: 4-8 years as a medical writer, focusing on redactions/anonymization of clinical documents per EMA Policy 0070, Health Canada PRCI, EUCTR regulation, and final rule-NIH.
Regulatory Knowledge: Strong understanding of disclosure regulations and quality review processes.
Disclosure Documentation: Experience in preparing disclosure documents (Protocol Registration Form, Result Registration Form) for clinicaltrials.gov and other clinical registries.
Clinical Study Understanding: Ability to comprehend protocols and clinical study reports from a disclosure perspective.
Fundamental Knowledge: Strong grasp of clinical trial disclosure fundamentals.

Job Responsibilities:

1. Authoring & Quality Assurance:

Execute project-specific activities with high quality and within defined timelines.
Review, edit, and quality-check clinical study documents, regulatory submissions, and disclosure commitments.
Conduct systematic quality control checks using pre-specified checklists.
Perform detailed analyses on processes and outputs.
Ensure adherence to client processes.

2. Additional Responsibilities:

Complete internal and client-specific training.
Assist in mentoring and training team members as required.

Qualification Requirements:

Education: Minimum graduate degree in life sciences.
Regulatory Knowledge: Familiarity with regulatory requirements and clinical development processes.
Technical Skills: Proficiency in MS Word, PowerPoint, and Excel.
Core Competencies:
- Strong analytical skills with scientific and clinical data.
- Professionalism and ownership of assigned work.
- High attention to detail and commitment to quality.
- Enthusiasm, proactivity, and teamwork.
- Ability to build client relationships.

Preferred Qualifications:

Degree: Bachelor of Science (preferred) or Bachelor of Arts (Social Sciences, English, Communications).
Grammar & Guidelines: Strong knowledge of English grammar, FDA & ICH regulations, and AMA style guide.
Independence & Leadership: Effective presentation, proofreading, and interpersonal skills.
Software Proficiency: Strong command of Word, Excel, PowerPoint, email, and the internet.
Clinical Research Knowledge: Familiarity with clinical research principles and data interpretation.

About Syneos Health:

Over the past five years, Syneos Health has worked on:

94% of all Novel FDA Approved Drugs.
95% of EMA Authorized Products.
200+ studies across 73,000 sites and 675,000+ trial patients.

At Syneos Health, we challenge the status quo and thrive in a competitive, ever-changing environment. Learn more about Syneos Health and be part of a team that makes a difference.

Additional Information:

Responsibilities listed in this job description are not exhaustive.
Syneos Health may assign additional tasks and job responsibilities as needed.
Equivalent experience, skills, or education may be considered for qualification.
Syneos Health complies with the Americans with Disabilities Act and provides reasonable accommodations where necessary.

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