Medical Writer - India (56829) at Praxis Precision Medicines, Inc.

Tuusula, Uusimaa, Finland -

Full Time

Start Date

Immediate

Expiry Date

19 Mar, 26

Salary

0.0

Posted On

19 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Writing, Regulatory Submissions, Clinical Trials, Collaboration, Attention to Detail, Communication, Critical Thinking, Self-Motivation, Organizational Skills, CNS Experience, Rare Disease Experience, ICH Guidelines, FDA Guidance, Veeva RIM, SOP Adherence, Editorial Support

Industry

Description

Job Details Job Location: Remote - Boston, MA 02110 Position Type: Contractor Travel Percentage: None Job Category: Biotech 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 Additional Information Company Overview Praxis Precision Medicines is a clinical-stage 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 careers@praxismedicines.com. 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.

Responsibilities

The Medical Writer will prepare medical and regulatory documents, serving as the writing lead on assigned documents. They will collaborate with cross-functional teams to ensure the timely completion of high-quality documents for clinical trials and regulatory submissions.