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

4-8 years

Not Disclosed

Gurugram

10 March 3, 2025

Job Description

Job Type: Full Time Education: BA/BS/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

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

Updated: February 19, 2025
Location: India-Asia Pacific - IND-Gurugram-DLF Downtown
Job ID: 25001397

Description

Senior Medical Writer
Come discover what our 25,000+ employees already know—‘Work Here Matters Everywhere.’ We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.

As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number; they’re our family, friends, and neighbors.

Why Syneos Health

#SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know each person’s unique contributions make a difference.
We believe our success is a direct result of the people who are driving it – you! We value your dedication to caring for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental, and financial.
We are continuously building the company we all want to work for and that our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong.

Job Summary

Clinical Trial Disclosure plays a critically important role in executing projects for Syneos global clients. The Senior Medical Writer works as part of high-performing teams on challenging assignments involving the processing of complex scientific, medical, and technical information.

Skills

4-8 years of experience as a medical writer.
Involvement in redactions/anonymization of clinical documents as part of preparation for different regulations (EMA Policy 0070, Health Canada PRCI, EUCTR regulation, Final Rule-NIH).
Expertise in regulations, quality review, client communication, and management.
Experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials.gov and other clinical registries is an advantage.
Strong understanding of Clinical Trial Disclosure fundamentals.

Job Responsibilities

1. Authoring and Quality Assurance of Project Activities

Execute project-specific activities with high quality and within defined timelines according to standard processes and operating procedures.
Mark/QC/Review and/or edit pertinent documents such as:
- Clinical study documents or any other regulatory submission documents (e.g., clinical study reports, patient narratives, clinical summaries) for different regulations (EMA Policy 0070, Health Canada PRCI, EUCTR regulation, Final Rule-NIH).
- Protocol and results summaries to support clinical trial disclosure commitments.
Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklists generated in the project or SOP.
Perform detailed analyses on planned and ad hoc bases, relating to processes and their outputs.
Ensure compliance with client processes.

2. Additional Activities

Completion of internal and client-specific training.
Assist in mentoring and training of team members, depending upon project requirements.

Qualification Requirements

Minimum of a scientific graduate degree in life sciences.
Good knowledge of regulatory requirements or guidance pertinent to the service line.
Understanding of clinical development processes, including principles of clinical study operations and ICH-GCP guidelines.
Clear written and verbal communication skills.
Proficiency in basic computer applications (e.g., MS Word, PowerPoint, Excel).
Strong understanding of clinical trial disclosure fundamentals.
Ability to demonstrate:
- Analytical capabilities with scientific and clinical data.
- Professional working environment.
- Ownership of assigned work.
- Commitment to high-quality outputs with attention to detail.
- Enthusiasm and proactivity.
- Effective teamwork.
- Ability to build rapport and relationships with project-specific client colleagues.

Qualifications

Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English, or Communications preferred) with relevant scientific and/or medical knowledge.
Extensive knowledge of English grammar, FDA and ICH regulations, and guidelines, as well as familiarity with AMA style guide.
Strong presentation, proofreading, interpersonal, and leadership skills with a team-oriented approach.
Proficiency in Word, Excel, PowerPoint, email, and Internet.
Familiarity with principles of clinical research and ability to interpret and present clinical data and complex information.

Get to Know Syneos Health

Over the past 5 years, we have worked with:

94% of all Novel FDA Approved Drugs.
95% of EMA Authorized Products.
Over 200 Studies across 73,000 Sites and 675,000+ Trial Patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered, so qualifications of incumbents may differ from those listed in the job description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants in performing essential job functions.

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