Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.
About This Role
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.
Job Responsibilities and Duties include, but are not limited to, the following:
- 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
Requirements / Qualifications
- 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
Experience, Knowledge and Skills
- 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
Salary & Benefits
The anticipated salary range for this role is $140,000 – $175,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.