Medical Writer

Company Description

At Novaspire Biosciences, we pride ourselves on being a trusted partner to the pharmaceutical industry, delivering comprehensive, high-quality clinical research services. We support pharmaceutical, Biotechnology, Medical Device, and Nutraceutical companies at every stage of the drug/product development lifecycle. Our core services include pharmacovigilance, expertly designed and executed clinical trials, accurate and high-quality medical writing, bioequivalence study support, and cutting-edge imaging studies. With over 75 years of combined experience, our GxP Consulting Services & Training team guides clients through GxP compliance challenges, ensuring clean data and industry readiness.

Role Description

·    Write and edit clinical and regulatory documents such as:

·    Protocols and Amendments

·    Investigator Brochures,

·    Informed Consent Documents

·    Case Report Forms,

·    Clinical Study Reports (CSRs)

·    Common Technical Document (CTD) modules (e.g., 2.5, 2.7) – not mandatory

·    Develop scientific content for publications (manuscripts, abstracts, and posters), slide decks, and white papers.

·    Ensure documents comply with ICH-GCP, regulatory agency requirements (FDA, EMA, etc.), and internal company templates and SOPs.

·    Interpret clinical and scientific data accurately and present it clearly for various audiences. Provide strategic guidance on document planning and development when required.

·    Collaborate with cross-functional teams including clinical, regulatory, pharmacovigilance, and biostatistics teams.

·    Maintain version control and contribute to timelines and quality control throughout the document lifecycle.

·    Provide strategic guidance on document planning and development when required.

·    Any other client specific medical writing activities as assigned from time to time.

·    Prepare and review the medical writing SOPs when delegated.

Train the team on medical writing related SOPs as required.

Qualifications

• Scientific Writing and Medical Writing skills
• Proficiency in Medical Communications and general Writing
• Strong Research abilities
• Excellent written and verbal communication skills
• Ability to work independently and collaborate with diverse teams
• Experience in the pharmaceutical or healthcare industry is a plus
• Bachelor's or Master's degree in a related field such as Life Sciences, Medicine, Pharmacy, or equivalent