Senior Medical Writer (56025)

Job Details

Job Location

Remote - Boston, MA

Remote Type

Fully Remote

Position Type

Full Time

Education Level

4 Year Degree

Travel Percentage

Minimum of 2x/year to Boston area

Job Category

Biotech

Description

Position Summary

As a Medical Writer at Praxis you'll use your abilities to provide complete, accurate, high quality, and compliant documents in support of our clinical trials and regulatory submissions. You'll apply your knowledge and expertise to collaboratively author required documents with support from the Associate Director of Medical Writing while also helping teams follow medical writing processes and style requirements. If the job sounds like a fit for you, we look forward to receiving and reviewing your application.

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
• 4+ 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
• 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

Compensation & Benefits

At Praxis, we’re proud to offer an exceptional benefits package that includes:

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
• Bonus program structured to pay on a quarterly basis
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
• Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, spa services, student loan repayment, sports fees and much more
• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)
  
  

To round out this world-class total rewards package, we provide base salary compensation in the range of $135k to $145k. Final salary range may be modified commensurate with job level, education, and experience.

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, 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.

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.

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