Medical Writer - India (56829)

Praxis is seeing a Medical Writer who will work under the guidance of the Associate Director, Medical Writing and will help support the needs of one or more clinical development programs at Praxis. You will be responsible for completing accurate, high quality, and regulatory compliant documents in support of clinical trials and regulatory submissions. This requires the knowledge and expertise to collaboratively author required documents with support and input from the Associate Director, Medical Writing while also helping other teams follow medical writing processes and style requirements. This position will be remote and located in India.

Primary Responsibilities

• Implements all activities related to the preparation of defined medical and regulatory documents, serving as writing lead on assigned documents or identifying when external writers are necessary for support
• Supports documents for regulatory submissions to US and global health authorities, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), protocols, investigator brochures, clinical study reports, briefing documents, regulatory responses to health authority questions, and scheduled reports.
• Collaborates with cross-functional team members, eg, Clinical Pharmacology, Toxicology, Research, Clinical Development, Regulatory Affairs, Biostats, Data Management, Quality, CMC, QC, etc., to ensure accurate and timely completion and delivery of high-quality, scientifically-sound documents, slide decks, and publications
• Supports clinical trial transparency and disclosures, including clinical trials registration and results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide
• Contributes to departmental development through editorial and review support for document templates, style standards, reviewer guidelines, and standard operating procedures to ensure consistent and high-quality deliverables
• Ensures adherence to relevant SOPs and internal best practices

Qualifications and Key Success Factors

• Bachelor's degree required within a scientific discipline. Advanced degree, CNS, and Rare Disease experience a plus.
• A minimum of 3 years of medical writing experience in Sponsor or CRO setting
• AMWA certification preferred
• Experience using medical writing systems and technologies including Veeva RIM
• Knowledge of drug development, study conduct processes, ICH guidelines, and FDA/EU guidance or demonstrated success within a regulated industry environment
• Represents the core Praxis values of Trust, Ownership, Curiosity, and Results
• Ability to think critically in a fast-paced environment with a keen sense of urgency and demonstrated ability in creating solutions
• Self-motivated, able to work autonomously, and able to be a key contributor to one or more high-functioning and collaborative teams
• Highly organized and detail-oriented with a passion to deliver quality results quickly
• Strong verbal and written communication skills with an ability to build relationships internally and externally
• Highest levels of professionalism, confidence, personal values, and ethical standards