Novaspire Biosciences, a leading name in clinical research and drug safety, is looking for a Medical Writer to join their Bengaluru team. This full-time, on-site opportunity is ideal for science graduates and postgraduates who have a passion for medical and scientific writing.
The role involves crafting high-quality clinical and regulatory documents, supporting global pharmaceutical and biotech organizations through various stages of the drug development lifecycle.
About Novaspire Biosciences
Novaspire Biosciences partners with global pharmaceutical, biotechnology, medical device, and nutraceutical companies to deliver comprehensive clinical research services. Their expertise spans pharmacovigilance, bioequivalence studies, medical writing, and imaging-based studies. With a seasoned team holding over 75 years of combined experience, Novaspire ensures quality, compliance, and scientific integrity across all deliverables.
Key Responsibilities
- Author and edit a wide range of clinical and regulatory documents:
- Study Protocols and Amendments
- Investigator Brochures
- Informed Consent Forms (ICF)
- Case Report Forms (CRF)
- Clinical Study Reports (CSR)
- Common Technical Document (CTD) modules (2.5, 2.7 – optional)
- Develop scientific content for publications, including abstracts, posters, manuscripts, and slide decks.
- Ensure adherence to ICH-GCP, FDA, and EMA requirements.
- Accurately interpret and present clinical data for various stakeholders.
- Collaborate with cross-functional teams (Regulatory, PV, Biostatistics, and Clinical Operations).
- Contribute to SOP development, training, and quality review processes.
Qualifications and Skills
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or equivalent.
- Strong command of medical writing and scientific communication principles.
- Excellent written and verbal communication skills.
- Experience in pharmaceutical or clinical research settings preferred.
- Ability to work independently and collaboratively in multidisciplinary teams.
- Proficiency in medical terminology, research interpretation, and document formatting.
Benefits
- Competitive salary and growth-oriented environment.
- Exposure to global clinical and regulatory projects.
- Mentorship from industry leaders in clinical research and GxP compliance.
- Opportunity to contribute to high-impact scientific and regulatory documentation.
How to Apply
