Medical Writer

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 mínimal 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

**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-XXXXXXXXXX

Expected Start Date: 14/01/2023