Orbis Clinical is seeking a remote-based Senior Director, Medical Writing  for 12 months.

Seeking a highly motivated, well-organized, and skilled Senior Director, Medical Writing to provide strategic and operational leadership across oncology programs spanning early- and late-stage development. This role is responsible for delivering high-quality regulatory and clinical documents that support global development and registration strategies.

You will partner closely with Clinical Development, Regulatory Affairs, Biometrics, and Clinical Operations to ensure scientifically rigorous, compliant, and timely documentation. The ideal candidate brings deep oncology expertise, including familiarity with complex trial designs, endpoints (e.g., ORR, PFS, OS), and evolving regulatory expectations.

What you’ll do:

• Lead authoring strategy and oversee the successful development of clinical and regulatory documents (e.g., INDs, NDAs, BLAs, MAAs, Protocols, IBs/DSURs, CSRs, Briefing Documents) in accordance with applicable global regulatory requirements
• Translate complex oncology and biomarker-driven data into clear, scientifically accurate, compliant, submission-ready documentation
• Plan and manage medical writing activities, timelines, and resources across multiple programs
• Lead cross-functional document reviews, resolve feedback, and drive documents to approval
• Work effectively with cross-functional teams by creating an atmosphere of openness and trust
• Oversee vendors, budgets and resources for medical writing
• Lead a medical writing team to successfully meet the portfolio needs

Requirements:

• Advanced degree (PhD, PharmD, MD, or MS) in life sciences
• 10-12 years of medical writing experience, in biotech/pharmaceutical industry, including 5+ years in a leadership role supervising a medical writing team
• Proven leadership experience supporting INDs and at least one major regulatory submission in oncology
• Demonstrated expertise in authoring and overseeing a broad range of clinical and regulatory documents
• Strong knowledge of global regulatory requirements (ICH, GCP, CTD/eCTD)
• Proven ability to manage complex projects and influence cross-functional teams
• Experience managing direct reports, contractors, and/or vendors
• Excellent written and verbal communication skills
• Experience with innovative technologies to expedite document preparation (e.g., artificial intelligence tools)
• Experience working in small to mid-sized biotech or fast-growth environments with novel oncology modalities
• Advanced knowledge of scientific medical writing principles, tools and practices in oncology.
• Strategic thinking, scientific rigor, strong leadership and team development with high attention to detail and quality focus.
• Strong interpersonal skills, including excellent written and effective communication skills with senior stakeholders which are essential in this collaborative work environment.
• Self-motivated, with initiative and the ability to take ownership of, and follow through on specific tasks, initiatives or programs.
• Ability to manage multiple priorities in a fast-paced environment
• Staff development experience a plus.

Compensation Details:

• Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. 
• The Pay Range for this position is $170-$180 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). .

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.