MEDICAL WRITER-II (inVentiv International Pharma Services Pvt. Ltd.)

  • Medical Writer
  • Full time
  • 2 months ago
  • Hyderabad

Job Information

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    Salary Not Disclosed Not Disclosed / Not Disclosed
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    Shift Round
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    No. of Openings 12 openings
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    Job Level : junior
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    Job Experience : 4-7Years
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    Job Qualifications bachelors or above

Job Description

Company Name: inVentiv International Pharma Services Pvt. Ltd.


Location: Hyderabad/Secunderabad

Experience: 4-7 years

Qualification: What were 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 and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. 
  •   Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach. 
  •   Strong proficiency in Word, Excel, PowerPoint, email, and Internet. 
  •   Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information. 

Job Description: Job responsibilities

  •   Mentors less experienced medical writers on projects, as necessary.
  •   Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. 
  •   Develops or supports a variety of documents that include but not limited to: 

     o    Clinical study protocols and clinical study protocol amendments;

     o    Clinical study reports;

     o    Patient narratives;

     o    Annual reports;

     o    Investigator brochures.

  •   Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
  •   Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. 
  •   Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.
  •   Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
  •   Performs on-line clinical literature searches, as applicable. 
  •   Working knowledge of drug development process and regulatory guidelines.
  •   Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing.
  •   Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
  •   Completes required administrated tasks within the specified timeframes.
  •   Performs other work-related duties as assigned. 
  •   Minimal travel may be required (less than 25%). 

Salary: Not disclosed

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