Medical writer

IGC Pharma is a USA-based pharmaceutical company dedicated to advancing innovative treatments to improve patient outcomes. As part of our commitment to high-quality clinical design, we are seeking a Medical Writer who will be responsible for designing, developing, reviewing, finalizing, and submitting clinical research documents such as clinical trial protocols to regulatory agencies and helping write scientific publications.

Job Description:
We are seeking a highly skilled medical writer with expertise in neurology or neuroscience to join our team in developing regulatory documents for submission to the regulatory agencies. The ideal candidate will play a key role in protocol design, literature review, and the preparation of documents supporting proposals for the treatment of neurological and neurodegenerative disorders, with a strong emphasis on Alzheimer’s disease. This role requires the ability to translate complex scientific concepts into clear, compliant documents, ensure thorough integration of current literature, and maintain alignment with global regulatory and industry standards.

Key Responsibilities:
-Develop innovative and effective protocol designs that meet regulatory requirements and scientific standards.
-Conduct comprehensive literature reviews to support protocol development, regulatory submissions, and scientific publications.
-Draft, review, and finalize regulatory documents, including INDs, briefing packages, drug designation requests, and submissions to the FDA and international agencies.
-Ensure all documents are scientifically accurate, clearly written, and compliant with global regulatory standards.
-Serve as the primary point of contact for protocol and study design issues, coordinating with internal teams to resolve them in a timely manner.
-Provide regular updates and reports to senior management on study design progress, challenges, and opportunities.
-Stay current with scientific and regulatory developments in neurology and neurodegenerative diseases, particularly Alzheimer’s disease, and integrate best practices into study design.

Qualifications:
-Advanced degree (MS, PhD, MD, or PharmD) in basic sciences neurology, neuroscience, pharmacology, psychology or a related life science field.
-At least 3-5 years of experience writing and editing scientific publications.
-Strong scientific background in neurology and neurodegenerative diseases, especially Alzheimer’s disease.
-Excellent scientific writing and communication skills, with the ability to translate complex science into clear, structured documents.
-Strong knowledge of regulatory requirements related to study design in clinical research.
-Proficiency in MS Word and strong computer skills.
-Exceptional attention to detail, strong organizational skills, and ability to manage multiple projects under tight timelines.
-Ability to adapt to a fast-paced and dynamic work environment.
-Excellent command of written and spoken English.

Interested candidates should submit their resume and a cover letter. Please include relevant experience in pharmaceutical quality control and regulatory compliance.

* Salary is negotiable depending on experience and academic background.

Profesional

Maestría

Medicina

Psicología

Posgrados en psicología y afines

3 años de experiencia

1 Vacante