Author, edit, QC, and publish high-quality clinical and regulatory documents in accordance with ICH, GCP, and company standards including: Clinical Study Protocols and Amendments, Informed Consent Forms (ICFs), Investigator Brochures (IBs), Clinical Study Reports (CSRs), Clinical sections of regulatory submissions (e.g., INDs, CTAs, NDAs, MAAs, briefing documents), Patient narratives and safety summaries.
Ensure all documents comply with regulatory guidelines (ICH, FDA, EMA), internal RayzeBio SOPs, and company style guides.
Interpret and present clinical data in a clear, concise, and scientifically accurate manner for internal and external stakeholders.
Coordinate with cross-functional teams (clinical, regulatory, biostatistics, data management, pharmacovigilance, clinical operations and other departments) for source data, input, and review.
Oversee planning, timelines, and resource management for medical writing deliverables across clinical programs.
Organize and facilitate document review cycles, manage version control, and oversee quality assurance for document finalization and submission.
Track writing assignments and ensure timely execution in line with program milestones and regulatory submission deadlines.
Serve as the primary point of contact for cross-functional teams regarding medical writing deliverables.
Manage outsourcing partners and medical writing consultants, when applicable.
Lead regular status meetings, provide risk mitigation strategies, and communicate project status to cross-functional teams.

Requirements

Advanced degree (PhD, PharmD, MD, or Master’s in Life Sciences or related field) preferred.
Minimum of 3 years of experience in clinical medical writing within the pharmaceutical, biotech, or CRO industry.
At least 2 years of experience managing medical writing projects or acting in a lead writer role.
Experience with oncology products required and radiopharmaceuticals a plus.
Independent professional who proactively communicates frequently and effectively.
Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision making.
Solid understanding of the clinical drug development process and regulatory requirements for global submissions, including familiarity with eCTD structure and submission process.
Excellent written and verbal communication skills with strong attention to detail and scientific accuracy.
Proficiency in Microsoft Office Suite, document management systems, and project tracking tools (e.g., MS Project, Smartsheet, Veeva).
Ability to manage multiple priorities in a matrixed environment with minimal supervision.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays)
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical medical writingregulatory submissionsclinical study protocolsinformed consent formsinvestigator brochuresclinical study reportspatient narrativessafety summariesproject managementoncology products

Soft skills

leadershipproject managementcommunicationattention to detailproactive communicationrisk mitigationcollaborationorganizational skillsindependencetimely execution

Certifications

PhDPharmDMDMaster’s in Life Sciences