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Axsome Therapeutics, Inc. · 2 months ago

Medical Writer, Clinical Development

New York, NY

Full-time

Onsite

Senior Level

$140K/yr - $175K/yr

6+ years exp

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. They are seeking a highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents in support of Clinical Development programs.

BiopharmaBiotechnologyTherapeutics

Responsibilities

Interpret, analyze, and synthesize complex clinical data and develop high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, and other documents in support of Clinical Development programs

Attend strategic meetings as applicable

Closely collaborate with, and apply strategic direction from, project leads and biostatisticians to manage and prioritize assignments and ensure deliverables are completed per time and quality goals

Develop documents for assigned programs in compliance with company standard operating procedures (SOPs)

Participate in developing timelines, managing review/approval workflows, and QC/publication readiness

Lead cross-functional teams to ensure team-wide agreement on documents content

Oversee outsourced medical writings projects and the associated vendor(s), as applicable

Ensure compliance and accountability for all regulatory documents prepared by the company

Qualification

Advanced scientific degreeClinical regulatory documentsPharmaceutical drug developmentPsychiatric disease knowledgeNeurological disease knowledgeStatistical Analysis PlansData mappingInterpersonal skillsDetail orientedProject management

Required

Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 6 years of relevant experience

Previous experience with preparation and QC of clinical regulatory documents: Protocols, IBs, CSRs, Module 2 Summary Documents, Clinical Overviews and Agency Briefing Document

A strong working knowledge of pharmaceutical drug development and GxP principles

Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

Highly knowledgeable in psychiatric and/or neurological disease areas is a plus

Track record of developing high-quality scientific documents

Ability to interpret, analyze, and synthesize complex clinical data into compelling and easily understood documents

Familiarity with the preparation of Statistical Analysis Plans and document data mapping

Experience with programmed outputs of tables, figures and listings for analysis and communication of clinical data

Ability to work collaboratively with and coordinate the efforts of team members to resolve comments and complete deliverables

Excellent interpersonal skills and judgement that facilitates working with cross-functional executive leadership and maintaining the security of proprietary information

Ability to manage/prioritize multiple projects under general supervision while working in a fast-paced environment

Flexibility for adapting to rapidly changing deadlines and priorities

Must be extremely detail oriented

Able to self-manage effort to maintain alignment with strategy and corporate goals