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NYSE American:CYBN
Cboe CA:CYBN

NYSE American:CYBN
Cboe CA:CYBN

Job
Listings

Job
Listings

United States, Remote

SENIOR MEDICAL WRITER

Position Summary

The Medical Writer will be responsible for providing deliverables throughout the life cycle of our research & development programs. This includes clinical study reports, regulatory submissions, manuscripts, and educational materials. The ideal candidate will have a strong background in medical science, particularly in mental health, and the ability to communicate complex scientific information clearly and effectively.

About Cybin

Cybin is a remote-based workplace that operates internationally and is growing daily. This growth provides numerous opportunities for advancement and development, making it an exciting time to join our team. We work across multiple time zones and with various internal and external partners. Our core values are the backbone of our business and guide our hiring process: we are a team of disciplined, high-performing, and results-oriented people who strive for excellence in our execution. Our mission is to revolutionize mental healthcare by developing differentiated, next-generation therapeutics.

Objectives
  • Author key regulatory documents including study protocols, investigator’s brochures, and regulatory submissions
  • Ensure the materials and documents prepared are compliant with PMRI standards, sponsor requirements, and regulatory guidelines
  • Collaborate with the required departments regarding relevant sections of the protocol and CSR
  • Review the design of electronic case report forms (eCRFs) and mock tables to ensure they align with the study protocol and meet clinical/medical requirements
  • Use study templates (e.g. protocol, ICF, CSR), check lists, and Training Manual to write and/or edit the required documents to ensure accuracy, clarity, quality, and consistency
  • Maintain familiarity with current industry practices as well as regulatory requirements and guidelines that affect medical writing
  • Perform literature review to provide scientific material needed for, but not limited to, background and introduction, study rationale, drug safety, and results discussion
  • Address sponsor comments related to protocols and CSRs
  • Prepare manuscripts for publication in peer-reviewed journals
  • Handle special projects and initiatives as needed
Competencies
  • Proficiency in Microsoft Office Suite
  • Excellent written and verbal communication skills
  • Ability to work independently and manage multiple projects simultaneously
  • Commitment to handling confidential information with discretion
  • Excellent follow-up and follow-through skills
  • Excellent organizational, multitasking, and time management skills
  • Excellent attention to detail and problem-solving skills
  • Commitment to working independently with minimal supervision
Education And Experience
  • Bachelor’s degree in a relevant scientific discipline (e.g., psychology, neuroscience, pharmacology)
  • At least five years’ experience in medical writing in industry-sponsored clinical trials
  • Excellent scientific writing, editing, data visualization and interpretation skills
  • Knowledge of ICH-GCP and other applicable legislation relevant to clinical trials
  • Understanding of the regulatory framework applicable to clinical trial documentation
  • Experience with regulatory submissions (e.g., IND, NDA, BLA
Physical Requirements
  • Prolonged periods sitting at a desk and working on a computer
  • Travel 1-2x per year
Benefits
  • Medical, Dental & Vision Coverage
  • Health Spending Account
  • Retirement Savings Plan
  • Internet and Mobile monthly stipend
  • Paid Time Off
  • Mandatory Office Closure December 25 – January 1 inclusive
Commitment to Diversity

As an Equal Opportunity Employer committed to meeting the needs of a multigenerational and multicultural workforce, Cybin Inc. recognizes that a diverse staff, reflective of our community, is an integral and welcome part of a successful and ethical business. We hire talent at all levels regardless of ethnicity, colour, national origin, age, religion, sexual orientation, gender identity or expression, family or parental status, veteran status, neurodiversity status, disability status, or any other basis protected by applicable law.

Contact

We are proud to provide accommodations during the recruitment process. Should you require accommodation, please contact us at HR@cybin.com, and we will work with you to meet your accessibility needs. We appreciate all applications; however only those candidates selected for an interview will be contacted.

If this position caught your eye, send us your resume!
https://www.linkedin.com/jobs/view/4131805704/