Company Name: inVentiv International Pharma Services Pvt. Ltd.
Designation: MEDICAL WRITER-II
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
Website Link: https://www.naukri.com/job-listings-medical-writer-ii-inventiv-international-pharma-services-pvt-ltd-hyderabad-secunderabad-pune-4-to-7-years-300721000509