Director, Medical Writing

Paylocity; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Annual bonus

Equity

Health benefits

Job summary

BBOT seeks a Director of Medical Writing to lead strategic and hands-on creation of clinical and regulatory documents for global submissions. You will partner with Clinical Development, Regulatory Affairs, and Clinical Operations to establish standards and scalable processes across the portfolio.

The role requires 12+ years in biopharma with 10+ years in medical writing, plus 3+ years of people leadership, and proficiency with Veeva RIM, EndNote, and common MS Office tools.

Qualifications

• Bachelor's degree in Life Sciences or related field is required.
• Advanced degree (PhD/PharmD/MD or Master's) preferred.
• Minimum 12 years in biopharma with 10+ years of medical writing.
• At least 3 years of people leadership or functional management.

Responsibilities

• Direct, hands-on medical writing for major regulatory documents (IND, NDA, BLA, MAA).
• Lead cross-functional alignment to ensure timely, high-quality submissions.
• Develop and implement medical writing strategy and standards.
• Oversee internal and vendor medical writing resources and budgets.
• Ensure compliance with FDA, EMA, ICH, and GCP guidelines.

Skills

Medical Writing

Leadership

Regulatory submissions

Strategic planning

Communication

Education

Bachelor's degree in Life Sciences

Advanced degree (PhD/PharmD/MD/Master)

Tools

MS Office

Adobe Acrobat

SharePoint

Veeva RIM

EndNote

Job description

BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information, visit BBOTx.com.

WHO YOU ARE

The Director, Medical Writing provides strategic and operational leadership for the Medical Writing function and is responsible for the planning, development, and delivery of high-quality clinical and regulatory documents that support BBOT's development programs and global regulatory submissions.

This individual serves as a strategic partner to Clinical Development, Regulatory Affairs, Clinical Operations, and other cross-functional leaders to ensure the timely delivery of scientifically rigorous and regulatory-compliant documentation. The Director is responsible for establishing medical writing standards, building organizational capabilities, and ensuring portfolio-wide execution of medical writing activities in support of corporate objectives.

RESPONSIBILITIES

Medical Writing

• Direct, hands-on authoring and leading complex, major regulatory document preparation (e.g., IND, NDA, BLA, and MAA, clinical protocol, IB, CSR, Agency meeting materials).
• Synthesize complex clinical and scientific data into key elements.
• Review and edit documents prepared by internal writers, contractors, or functional contributors to ensure quality and adherence to standards.
• Partner with study teams to develop key messages from clinical study data.
• Drive alignment across functions to ensure high-quality, timely, and efficient execution of clinical and regulatory documentation.

Functional Leadership and Strategy

• Develop and execute the Medical Writing functional strategy aligned with corporate and development objectives.
• Establish and maintain department goals, performance metrics, standards, and best practices to ensure high-quality and efficient document delivery.
• Build, scale, and continuously improve Medical Writing processes, systems, templates, and standards.
• Provide strategic leadership and oversight for all medical writing activities across the clinical portfolio.
• Serve as the functional leader and subject matter expert for Medical Writing within the organization.

Portfolio and Regulatory Leadership

• Lead strategic planning and oversight of medical writing deliverables across all development programs and regulatory submissions.
• Influence development and regulatory strategies through active participation in portfolio planning and decision-making activities.
• Develop integrated document strategies and submission plans for major regulatory submissions, including INDs, NDAs, BLAs, MAAs, and health authority meeting packages.
• Partner with cross-functional teams to develop messaging strategies and ensure consistent communication of clinical data across regulatory documents.
• Provide strategic guidance on document content, structure, and messaging to support successful regulatory interactions and submissions.
• Ensure all deliverables are completed in compliance with applicable regulations, company SOPs, ICH guidelines, and industry standards.

Organizational Leadership and Resource Management

• Develop and manage Medical Writing resource plans, including internal staffing, contractor oversight, and vendor management strategies.
• Manage departmental budgets and forecasting activities to ensure efficient allocation of resources.
• Recruit, mentor, develop, and retain high-performing medical writing professionals.
• Provide leadership, coaching, and performance management for direct reports and contribute to succession planning and organizational development.
• Establish an effective operating model that supports organizational growth and evolving business needs.

Quality and Compliance

• Establish and maintain Medical Writing governance, standards, templates, and quality processes.
• Ensure inspection readiness and compliance with global regulatory requirements, including FDA, EMA, ICH, and GCP guidelines.
• Oversee quality review processes to ensure scientific accuracy, consistency, and regulatory compliance across all documents.
• Lead continuous improvement initiatives that enhance efficiency, quality, and scalability of Medical Writing operations.

Additional Responsibilities

• Provide strategic oversight and guidance for the preparation of clinical and regulatory documents as needed.
• Perform other duties as assigned.

EDUCATION AND QUALIFICATIONS

• Bachelor's degree in Life Sciences or related discipline required; advanced degree (PhD, PharmD, MD, or Master's degree) preferred.
• Minimum of 12 years of experience in the biopharmaceutical industry, including at least 10 years of progressive medical writing experience.
• Minimum of 3 years of people leadership or functional management experience.
• Demonstrated success leading Medical Writing activities for complex global regulatory submissions, including INDs, NDAs, BLAs, and MAAs.
• Deep expertise across the clinical trial document lifecycle, including protocols, Investigator's Brochures, Clinical Study Reports, CTD summaries, and health authority briefing documents.
• Extensive knowledge of global regulatory requirements and guidelines, including FDA, EMA, ICH, and GCP.
• Proven experience building and managing medical writing teams, contractors, and external vendors.
• Demonstrated ability to independently lead in a fast-paced, dynamic, and highly collaborative biotechnology environment.
• Strong strategic thinking, organizational, and project leadership skills.
• Excellent written and verbal communication skills and the ability to influence at all levels of the organization.
• Proficiency with standard business applications and industry systems, including Microsoft Office, Adobe Acrobat, SharePoint, Veeva RIM, EndNote, and related document management platforms.

WHAT WE OFFER

At BBOT, we strive to provide a market-competitive total rewards package, including base pay, annual performance bonus, company equity, and comprehensive health benefits. The final compensation package will depend on factors including experience, skills, education, location, and performance throughout the interview process.