Senior Medical Writer - US

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

Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

At Praxis, we believe that taking care of our people (and

their

people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together!

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Annualized Base Salary

$130,000

medical writing activities for one or more clinical development programs at Praxis, as directed by the Associate Director, Medical Writing.

, high quality, and regulatory compliant documents in support of clinical trials and regulatory submissions.

documents with support from the Associate Director, Medical Writing while also helping teams follow medical writing processes and style requirements.

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

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