Principal Medical Writer (Csr, Ib,Protocol)

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

Principal Medical Writer (CSR, IB, Protocol)
Updated: February 10, 2025
Location: India-Asia Pacific - IND-Gurugram-DLF Downtown, India
Job ID: 25001396-IND501

Description:

Principal Medical Writer
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 brings the customer and the patient to the center of everything that 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 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 is what 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. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong.

Job Responsibilities:

Mentors and leads less experienced medical writers on complex projects, as necessary.
Represents the Medical Writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding a writing project.
Advises clients and study teams on data presentation and production strategies to ensure client objectives/expectations are met and quality standards are maintained.
Develops good working relationships with internal and external colleagues.
Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
Develops or supports a variety of documents, including but not limited to:
- Clinical study protocols and protocol amendments
- Clinical study reports
- Patient narratives
- Clinical development plans
- IND submissions and annual reports
- Integrated summary reports
- NDA and (e)CTD submissions
- Investigator brochures
- Clinical journal manuscripts, abstracts, and client presentations
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency.
Serves as a peer reviewer providing comments to enhance clarity, accuracy, relevance, and overall quality.
Adheres to established regulatory standards, including ICH-E3 guidelines, company SOPs, client standards, and company/client-approved templates.
Conducts online clinical literature searches, as applicable.
Engages in continuous professional development to keep pace with regulatory guidance and client expectations.
Understands budget specifications for assigned projects, working within budgeted hours and communicating changes to medical writing leadership.
Completes required administrative tasks within specified timeframes.
Performs other work-related duties as assigned. Minimal travel may be 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 and expertise.
Extensive knowledge of English grammar with familiarity with the AMA style guide.
Strong understanding of FDA and ICH regulations and guidelines preferred.
Effective presentation, proofreading, and interpersonal skills, ensuring a team-oriented approach.
Strong proficiency in Word, Excel, PowerPoint, email, and the Internet.
Ability to interpret and present clinical data and other complex information.

Get to Know Syneos Health:
Over the past five years, we have 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. Learn more about Syneos Health.

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 will determine what qualifies as equivalent to the qualifications described above.
Nothing contained herein should be construed to create an employment contract.
The company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations.

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