Your browser does not support javascript! Please enable it, otherwise web will not work for you.

Medical Writer - Bengaluru/Bangalore - MMSH @ MMSH Clinical

Home > Drug Regulatory Affairs / Documentation

 Medical Writer - Bengaluru/Bangalore - MMSH

Job Description

Job Description

  • Practices good internal and external customer service
  • Responsible for scientific medical writing and producing high quality documents
  • Understands ICH guidelines, as applicable to medical writing for clinical studies
  • Creates medical writing training exercises; mentors new medical writers
  • Trains via self-study and self-practice independently and explores advanced topics related to medical writing and/or drug development
  • Strong understanding of MS Word for advanced writing techniques
  • Proficient with styles of writing for various document types
  • Strong proficiency with client templates & style guides
  • Interacts directly and independently with client and demonstrates strong client interaction skills
  • Complete competence reviewing blinded data tables, listings, and graphs for study report writing
  • Writes documents without oversight
  • Addresses client comments during document lifecycle, including critical review of comments and value-added suggestions
  • Assumes responsibility for quality and integrity of documents
  • Independently implements and validates QC findings in compliance with NC Handling Procedure
  • Conducts thorough self-review of deliverables prior to release to client; serves as high level reviewer for others
  • Follows processes related to project management as appropriate for medical writing projects (e.g. updating PSS etc.)
  • Participates in improvements to departmental processes and recommends efficiencies
  • Demonstrates internal and external leadership skills for projects with minimal management oversight
  • Complies with Document Control Procedure Complies with Record Control Procedure
  • Ensures compliance to applicable ISMS policies and procedures

Job Requirements (Minimum Education / Experience / Training / Skills)

  • College graduate in scientific, medical, clinical discipline or related field, or related experience
  • Has high level knowledge of drug development as pertains to medical writing; has the ability to apply drug development knowledge during production of high quality documents
  • Hands-on experience with clinical trials and pharmaceutical development
  • 2-6 years writing experience in the pharmaceutical or CRO industry preferred
  • Skilled in the writing of various documents
  • Excellent scientific writing skills
  • Understands scientific, medical, and/or clinical data
  • Proficiency with MS Office applications
  • Excellent organizational and communication skills Familiarity with ISO 9001:2008 requirements

Job Classification

Industry: Pharma / Biotech / Clinical Research,
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: Drug Regulatory Affairs/Documentation
Role: Drug Regulatory Affairs/Documentation
Employement Type: Full time

Education

Under Graduation: Any Graduate in Any Specialization
Post Graduation: Post Graduation Not Required
Doctorate: Doctorate Not Required

Contact Details:

Company: MMSH Clinical

+ View Contactajax loader


Keyskills:   CRO ISMS Project management Pharma Clinical trials Life sciences Customer service MS Office Medical writing clinical data

 Job seems aged, it may have been expired!
 Fraud Alert to job seekers!

₹ Not Disclosed

MMSH Clinical

MMSH Clinical Research Pvt Ltd