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Director, Medical Writer
3 months ago
Position: Director, Medical Writer
Hiring Manager: Sondra Smyrnios, SVP, Head of Global Clinical Operations
Location: Remote
Travel: 0-5% of (domestic) travel
Position Summary:
The Medical Writer at Pyxis Oncology ('PYXS' or 'Company') plays a critical role in the development and execution of clinical studies and specializes in authoring, editing, and managing timelines for the development of core clinical documents, summary documents, package inserts and other documents for submission to regulatory agencies. This hands-on role provides recommendations for the development of formats and guidelines for documentation. This role requires a combination of scientific knowledge, attention to detail, and excellent writing skills.
Responsibilities:
- Research, author, and edit clinical documents including study synopsis, protocols, amendments, Investigator Brochures, clinical study reports, etc.
- Prepares summary documents, package inserts and other documents that may be submitted to the Food and Drug Administration including meeting requests, briefing packages, annual updates, IND, and BLA/NDA submissions.
- Prepares timelines and coordinates roundtable meetings for review, comment consolidation, and finalization of clinical documents. Oversees medical writing consultants/contractors as applicable.
- Assists in the development of processes, formats, and guidelines for clinical documentation.
- Work closely with clinical researchers, statisticians, and other stakeholders to ensure the protocol aligns with the study goals and regulatory requirements.
- Maintains version control and storage for protocols, amendments, and other documents.
- Ensure that all protocols comply with regulatory and ethical standards.
- Keeps abreast of professional information and writing technology through networking, independent research of publications and materials, conferences, etc.
- Other duties as periodically assigned.
- Demonstrate PYXS core values: be of service, be clever, be gutsy, be tenacious, and be you.
Qualifications:
- Minimum of a bachelor's or equivalent University/College degree is required. Advanced degree (Masters, PhD) preferred.
- Minimum 5 years of relevant medical writing experience is required; including but not limited to the ability to interpret, summarize, and present statistical and medical information.
- Experience in oncology required.
- Maintain and apply knowledge of the industry, company, and regulatory guidelines.
- Must have strong attention to detail.
- Excellent oral (including presentation) and written communication, and project management skills.
- The ability to work independently and without direction as needed.
- The ability to build and maintain positive relationships with cross-functional team members.
- Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
- Eligible to work in the United States without sponsorship.
The full-time annual base salary for this position is estimated to range between $203,000 to $237,000. The final compensation package offered to a successful candidate will consider a number of factors including but not limited to prior experience, relevant expertise, education, skills, qualifications and certifications, business needs, and market conditions.
Pyxis Oncology also provides eligible employees a comprehensive and competitive total rewards package including but not limited to a discretionary annual bonus (related to company and individual performance), equity, health insurance (including medical, dental, and vision), company paid life and disability insurance, unlimited vacation with paid holidays, a 401(k) plan, a flexible work model, and paid parental leave.
