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Sr Medical Writer (Csr, Ib, Protocol) |Homebased India|

2+ years
Not Disclosed
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

Sr Medical Writer (CSR, IB, Protocol) | Homebased India
Updated: February 13, 2025
Location: India-Asia Pacific - IND-Gurugram-DLF Downtown, India
Job ID: 25001430-IND501

Description

Senior 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 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. Bringing together diverse thoughts, backgrounds, cultures, and perspectives enables us to create a place where everyone feels like they belong.

Job Responsibilities

  • Mentors and leads less experienced medical writers on complex projects, as necessary.
  • Acts as lead for assigned writing projects.
  • 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 clinical 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
  • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
  • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency.
  • Interacts with department heads and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
  • Serves as a peer reviewer on internal review teams, providing review comments on draft and final documents.
  • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, Company Standard Operating Procedures, client standards, and Company and/or client-approved templates when completing medical writing projects, on-time and on-budget.
  • Performs online clinical literature searches, as applicable.
  • Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
  • Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
  • Completes required administrative tasks within the specified timeframes.
  • Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

Qualifications

What we’re looking for:

  • 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 and expertise.
  • Extensive knowledge of English grammar, FDA and ICH regulations and guidelines, as well as familiarity with the AMA style guide.
  • Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills, ensuring a team-oriented approach.
  • Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
  • Ability to demonstrate a familiarity with the principles of clinical research and to interpret and present clinical data and other 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 equivalency to the qualifications described above.
  • 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 the essential functions of the job.

 

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