NovoBliss Research Pvt Ltd Hiring for Medical Writer Job at Gāndhīnagar Full Time

– A bachelor’s or master’s degree – in Biotechnology, Pharmacology, –

– Pharmacognosy, or a health science field 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 and 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 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, out of box thinker, Have to go-getter attitude, who wishes to grow together with a start-up company

Job Location: Shaligram Lakeview, Nr. Vaishnodevi Circle, Khoraj, Gandhinagar – 382421

JOB RESPONSIBILITIES:

– 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 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.

Industry
Research

Employment Type
Full-time

Job Type: Full-time

Salary: ₹18,000.00 – ₹25,000.00 per month

Schedule:

• Day shift

Supplemental pay types:

• Yearly bonus

Ability to commute/relocate:

• Near Vaishnodevi cross roads, Gandhinagar – 382421, Gujarat: Reliably commute or planning to relocate before starting work (Required)

Experience:

• protocol writing: 1 year (Preferred)

Speak with the employer
+91 8849498928
Expected Start Date: 14/01/2023