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Sr Medical Writer

2+ years
₹8,00,000 - ₹12,00,000 per annum
10 May 23, 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

Location: India-Asia Pacific - IND-Home-Based
Updated: May 8, 2025
Job ID: 24003298


Description:
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 we do. We continuously seek ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.

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


Why Syneos Health:

  • Passionate about developing people through career development and progression, supportive line management, and technical/therapeutic training.

  • Committed to a Total Self culture where you can authentically be yourself.

  • Embracing diversity of thoughts, backgrounds, cultures, and perspectives to create a workplace where everyone feels they belong.


Job Responsibilities:

  • Mentor and lead less experienced medical writers on complex projects as needed.

  • Act as lead for assigned writing projects.

  • Manage medical writing activities associated with individual studies with minimal supervision.

  • Develop or support various documents including:

    • Clinical study protocols and 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

  • Identify and propose solutions for issues arising during writing, escalating when appropriate.

  • Review statistical analysis plans and table/figure/listing specifications for content, grammar, and consistency.

  • Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams as needed.

  • Serve as a peer reviewer on internal review teams.

  • Adhere to regulatory standards (e.g., ICH-E3), SOPs, client standards, and approved templates.

  • Perform clinical literature searches as applicable.

  • Maintain familiarity with industry practices, regulatory requirements, and guidelines affecting medical writing.

  • Manage budgets and communicate changes to leadership.

  • Complete administrative tasks on time.

  • Perform other duties as assigned. Minimal travel (<25%) may be required.


Qualifications:

  • Bachelor of Science degree with relevant writing experience, or Bachelor of Arts (Social Sciences, English, Communications preferred) with scientific/medical knowledge.

  • Extensive knowledge of English grammar, FDA and ICH regulations, and familiarity with AMA style guide.

  • High degree of independence with strong presentation, proofreading, interpersonal, and leadership skills.

  • Proficient in Word, Excel, PowerPoint, email, and Internet.

  • Familiarity with clinical research principles and ability to interpret and present clinical data and complex information.


About Syneos Health:
Over the past 5 years, we have worked with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products, 200+ studies across 73,000 sites, and 675,000+ trial patients.

We encourage initiative and challenging the status quo in a highly competitive and evolving environment.


Additional Information:
Tasks and responsibilities are not exhaustive and may change at the company's discretion. Equivalent experience or education may be considered. This is not a contract of employment. The company complies with all legal obligations including the EU Equality Directive and the Americans with Disabilities Act.


Estimated Salary: ₹8,00,000 - ₹12,00,000 per annum (based on market standards in India for senior medical writer roles)