Medical Writer - India
Medical Writer - India
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1 Vacancy
Job Description
Job Details
Description
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 crossfunctional 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 highquality scientificallysound documents slide decks and publications
- Supports clinical trial transparency and disclosures including clinical trials registration and results posting on clinicaltrials 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 highquality deliverables
- Ensures adherence to relevant SOPs and internal best practices
Qualifications and Key Success Factors
- Bachelors 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 fastpaced environment with a keen sense of urgency and demonstrated ability in creating solutions
- Selfmotivated able to work autonomously and able to be a key contributor to one or more highfunctioning and collaborative teams
- Highly organized and detailoriented 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
Additional Information
Company Overview
Praxis Precision Medicines is a clinicalstage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust Ownership Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity Equity & Inclusion
Guided by our core values at Praxis Precision Medicines Inc. we continue to DARE FOR MORE to advance promote and champion diversity equity and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race religious creed color gender identity or expression age national origin sexual orientation disability genetics military service and veteran status or any other characteristic protected by federal state or local laws.
Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity please report it to .
Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
Employment Type
Contract
