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
