Friday, April 19, 2024
HomeJobsBDSLooking for a Medical Writer? Join NovoBliss Research and Ignite Your Career

Looking for a Medical Writer? Join NovoBliss Research and Ignite Your Career

Medical Writing Jobs – Vacancy at NovoBliss Research Pvt Ltd

Role: Medical Writer

Company: NovoBliss Research®️ Private Limited

Location: Gandhinagar, Gujarat, India

Qualifications:

  • A Master’s degree in pharmacology, Pharmacognosy, or a health science – BDS, MBBS is a standard prerequisite for Medical Writers.
  • Capable of working independently with minimal supervision and also as part of a team
  • Skilled with standard computer programs including the MS Office suite (Word, Excel, PowerPoint)
  • Possess superior analytical organizational and time management skills
  • Good Inter-personal & communication skills (Written and Verbal)
  • Thorough understanding of the drug development process with sound knowledge of ICH-GCP
  • Comprehensive writing skills with a good command of written and spoken English
  • Self-motivation and ability to work independently

Experience: 0-2 years of relevant clinical research experience

Qualities: Ready to learn new things, box thinker, Have to go-getter attitude, who wishes to grow together with a start-up company

Job Responsibilities:

  • Medical Writing Jobs – Vacancy at NovoBliss Research Pvt Ltd
  • Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents, and related clinical documents, such as abstracts, posters, presentations, and manuscripts
  • Participates in scientific communication planning, including the development of strategic medical communication plans
  • Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
  • Collaborates with clinicians, clinical scientists, and biostatisticians, to interpret study results and ensure study results and statistical interpretations are accurately and reflected in relevant documents
  • Works closely with the study team to reach a consensus on timelines for deliverables
  • Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance
  • Understands the functions and roles within the study team and aligns with them in the delivery of documents to meet project-related goals and meet external results disclosure obligations
  • Manages all aspects of CSR production and ensures project delivery
  • Ensures that medical writing deliverables conform to the International Conference on Harmonization (ICH) and other relevant regulatory guidelines
  • Creates and maintains standard operating procedures and work instructions for the preparation and maintenance of compliant medical writing deliverables
  • Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates to improve quality, efficiency, and productivity
  • Align with department management to set a strategy for meeting department goals

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