Medical Writer, Clinical Development

Axsome Therapeutics•New York, NY

13d•$140,000 - $175,000•Onsite

About The Position

Axsome Therapeutics is seeking a highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents including protocols and clinical study reports. This is a key position within the Clinical Development Group with ample opportunity to make real impact. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.

Requirements

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

Nice To Haves

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

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