Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.About This Role:Axsome Therapeutics is seeking a highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents including protocols, clinical study reports, manuscripts, conference abstracts, and posters. This is a key position within CNS scientific communication 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 complex data and develops high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, publications and other documents in support of Medical Affairs, RWE/HEOR and/or Clinical Development programs
- Attend strategic meetings as applicable
- Closely collaborate with, and apply strategic direction from, project and publication leads and biostatisticians in order to manage and prioritize assignments to ensure deliverables are completed per time and quality goals
- Previous experience with preparation and QC of various document types: core clinical documents (protocols, IBs, CSRs, etc.), Health Authority Submission documents (Agency Briefing Documents, eCTD Summary Documents, Orphan Drug Applications), etc is a plus
- Develops documents for assigned programs in compliance with company standard operating procedures (SOPs)•This may include developing timelines, review/approval workflow management, and/or QC/publication readiness
- Work with cross-functional internal teams to ensure wide acceptability of documents and consensus of content
- Oversee outsourced medical writings projects and the associated vendor(s), as applicable
- Critically analyze, synthesize and present complex information
Requirements / Qualifications
- Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 5-8 years relevant experience
- A strong current working knowledge of the pharmaceutical environment is required
- Must be able to work on-site Mondays, Tuesdays and Thursdays
Experience and Knowledge:
- Highly knowledgeable in the relevant disease areas
- Track record of developing high-quality scientific documents
- Ability to interpret, evaluate, and communicate (in a variety of formats and styles) complex scientific and clinical data
- Expertise in use of online and other data sources for literature searches and information
- General knowledge of the drug development and approval processes and GXP principles
- Ability to work with cross-functional executive leadership and exposure to sensitive information, necessitating considerable use of tact, diplomacy, discretion, and judgment
- Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables
- Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment
- Flexible and able to adapt to changing deadlines and priorities
- Excellent written, verbal, and interpersonal communication skills
- Highly attentive to detail
- Able to self-manage effort to maintain alignment with strategy and corporate goals
Salary and Benefits:The anticipated salary range for this role is $160,000 - $180,000. 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.