Medical Writer, India

Location:  This position will be remote, and located in India.

The Opportunity
Working under the guidance of the Associate Director, Medical Writing, this role is responsible for medical writing activities for one or more clinical development programs at Praxis.  The individual will complete 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.

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
• 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
• The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position. Work is performed in a remote, work from home environment. The employee is regularly required to sit; use hands and fingers; reach with hands and arms; and talk and hear. The employee is occasionally required to stand, walk, and climb or balance. Movement through sites and labs may occasionally be required as employee may need to visit these environments. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Visual acuity is required to read and produce accurate materials. Use of keyboards and cellular devices.