Novaspire Biosciences, a trusted partner in the pharmaceutical industry, is hiring a Medical Writer in Bengaluru, Karnataka. If you have a passion for scientific writing and medical communications, this full-time, on-site role offers the opportunity to craft high-quality clinical and regulatory documents while collaborating with cross-functional teams in the pharmaceutical and biotechnology sectors.
Key Responsibilities
As a Medical Writer at Novaspire Biosciences, you will:
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- Write, edit, and review clinical and regulatory documents including:
- Protocols and Amendments
- Investigator Brochures
- Informed Consent Documents
- Case Report Forms (CRFs)
- Clinical Study Reports (CSRs)
- Common Technical Document (CTD) modules (e.g., 2.5, 2.7) – optional
- Develop scientific content for publications, abstracts, posters, slide decks, and white papers.
- Ensure compliance with ICH-GCP guidelines, regulatory requirements (FDA, EMA), and internal SOPs.
- Accurately interpret clinical and scientific data and present it clearly to varied audiences.
- Collaborate effectively with clinical, regulatory, pharmacovigilance, and biostatistics teams.
- Maintain version control, adhere to timelines, and ensure quality across all documents.
- Prepare and review medical writing SOPs and provide training as required.
- Participate in client-specific medical writing activities and provide strategic guidance on document planning.
Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Medicine, Pharmacy, or equivalent.
- Strong scientific writing and medical writing skills.
- Proficiency in medical communications and general writing.
- Strong research abilities and excellent written/verbal communication skills.
- Ability to work independently and collaboratively with diverse teams.
- Experience in pharmaceutical or healthcare industries is a plus.
Benefits
- Opportunity to work with a leading pharmaceutical research and consulting company.
- Exposure to clinical trials, pharmacovigilance, and regulatory documentation.
- Collaborative environment with opportunities for professional growth.
- Hands-on experience with high-quality scientific publications and GxP compliance.
How to Apply
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