Sr Medical Writer (Redaction)

Syneos Health

4-8 years

Not Disclosed

India

10 April 30, 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

Sr Medical Writer (Redaction)
Updated: March 26, 2025
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002334

Description

Sr Medical Writer (Redaction)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, built to accelerate customer success. We translate unique 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 continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with but also to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are passionate about developing our people through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for, and our customers want to work with. Why? Because when we bring together a 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. He/she works as part of high-performing teams on challenging assignments involving the processing of complex scientific, medical, and technical information.

Job Responsibilities

1. Authoring and Quality Assurance of Project Activities

Executes project-specific activities with high quality and in defined timelines according to standard processes and operating procedures.
Marking/QC/Review and/or editing of pertinent documents such as:
- Clinical study documents or any other documents for regulatory submission (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 performs quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP.
Performs detailed analyses on a planned and ad hoc basis, relating to processes and their outputs.
Ensures adherence to client processes.

2. Additional Activities

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

Qualifications

What We’re Looking For

4-8 years of experience as a medical writer, specifically in redactions/anonymization of clinical documents as part of preparation for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH).
Candidate should be well-versed in all related regulations, perform 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 will be an added advantage.
Candidate should understand and comprehend protocols and clinical study reports from a disclosure perspective.
A good understanding of clinical trial disclosure fundamentals is expected.

Educational Requirements:

A minimum of a scientific graduate degree in life sciences.
Good knowledge of regulatory requirements or guidance pertinent to the service line.
Clear written and verbal communication skills.
Proficiency in basic computer applications (e.g., MS Word, PowerPoint, Excel).

Core Competencies for This Role:

Analytical capabilities with scientific and clinical data.
Ability to work in a professional environment.
Ownership of allocated tasks.
Commitment to high-quality outputs, including attention to detail.
Enthusiasm and pro-activity.
Effective team working and relationship building.

Get to Know Syneos Health

Over the past 5 years, Syneos Health has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and 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.

Additional Information:

Tasks, duties, and responsibilities 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. The company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate.

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Sr Medical Writer (Redaction)

Job Description

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