Medical Writer – India

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

We are currently looking for a Medical Writer in India.

The role:

Excelya is looking to collaborate with a full-time role of Medical Writer based in India part of an international sponsor-dedicated team. A minimum 2+ years of Medical Writing experience, excellent knowledge of English language are required for this role.

The Medical Writer is responsible for the writing of Narratives (Automated/Semi Automated) as well as many clinical and regulatory documents (e.g. Clinical Study Reports, Common Technical Documents, Investigator Brochures, Protocols) and other medical writing tasks as requested by their team. They must maintain a high degree of efficiency, commitment to deadlines, delivering high-quality medical writing activities in compliance with the client’s and/or EXCELYA’s SOPs and applicable legislation.

Responsibilities:

1. Conducts the QC of clinical regulatory documents to timely completion before approval:
2. Proofreads documents for grammatical errors, and checks against data source (internal consistency within a document and across documents).Performs cross-referencing, fact-checking, and general quality assessments of documents.
3. Documents include but are not limited to: clinical study protocols and amendments, clinical study reports, informed consent forms, lay summaries, narratives, IND/IMPD/BRA, Investigator Brochures, clinical summaries and overviews and regulatory responses.
4. Delivers documented quality review comments/checklist to document author through resolution.
5. Conducts the QC of clinical regulatory documents to timely completion before approval.
6. Interacts regularly with Medical Writers and other team members to resolve QC findings.
7. Provides deliverables to Medical Writers.
8. Ensures compliance with Medical Writing conventions, processes, and applicable regulatory guidelines
9. Reviews documents written within Excelya, as well as those authored externally