Objective

Essential Functions

• Own the end-to-end medical writing function, including planning, resourcing, execution, and delivery of regulatory and scientific documents across all stages of development.
• Provide strategic input into development and regulatory strategy through authorship planning, document sequencing, and content alignment.
• Initially serve in a hands-on capacity by personally authoring and/or leading the drafting, review, and finalization of core regulatory and scientific documents, while building and scaling the medical writing function over time.
• Serve as the accountable medical writing lead for regulatory submissions, ensuring consistency, completeness, and submission readiness across all deliverables.
• Act as the primary medical writing representative in cross-functional governance forums and program-level decision-making.

• Lead the development of complex, integrated regulatory documents as programs advance, including INDs, NDAs, MAAs, briefing documents, and responses to regulatory authorities.
• Provide senior-level leadership in the development of clinical trial protocols, clinical study reports, Investigator Brochures, periodic safety updates, safety narratives, and scientific publications.
• Provide expert guidance on oncology-specific documentation, including oncology protocols, and benefit-risk assessments.
• Ensure alignment with ICH, FDA, EMA, and other global regulatory standards.
• Establish best practices, templates, and document standards to enhance consistency, quality, and efficiency.

• Ensure all written materials meet regulatory requirements, company SOPs, and inspection-ready standards, and support regulatory inspections and audits related to clinical and regulatory deliverables.
• Establish and monitor key performance indicators (KPIs) for medical writing quality, timelines, and review cycle efficiency.
• Develop and implement quality control processes to enhance document accuracy, clarity, and compliance.
• Lead continuous improvement initiatives to optimize medical writing processes and cross-functional collaboration.

• Lead the selection, onboarding, and oversight of external medical writing vendors, ensuring quality, consistency, and adherence to company standards.
• Manage internal and external resourcing strategies to meet program timelines and corporate milestones.

• Partner closely with clinical development, regulatory affairs, biostatistics, pharmacovigilance, and other stakeholders to ensure seamless integration of medical writing into development programs.
• Lead and mentor a team of medical writers, fostering technical excellence, accountability, and professional development.
• Cultivate a culture of collaboration, innovation, and high performance within the medical writing function.

• Serve as a subject matter expert in oncology medical writing, maintaining current knowledge of scientific, clinical, and regulatory advancements.
• Represent the medical writing function in internal and external interactions, including regulatory meetings, advisory boards, and industry forums.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education / Experience

• Advanced degree in Life Sciences, Medicine, or a related field; PhD preferred.
• Minimum of 12 years of medical writing experience, with significant focus on oncology and regulatory submissions.
• Demonstrated experience leading medical writing strategy and delivering complex regulatory documents across development stages.
• Proven experience supporting regulatory interactions and submissions (IND, NDA, MAA).
• Strong leadership experience with the ability to build, manage, and mentor high-performing teams.
• Experience with document management systems and tools (e.g., CoAuthor or similar platforms) preferred.

• Deep understanding of ICH-GCP and global regulatory requirements.
• Strong strategic thinking and execution capabilities in a fast-paced environment.
• Exceptional written and verbal communication skills with strong attention to detail.
• Ability to influence cross-functional stakeholders and senior leadership.
• Strong organizational and project management skills, with the ability to manage multiple priorities.
• Adaptability to a dynamic, growth-stage company environment.

Work Environment

• Work is primarily performed in a remote/home-office setting; prolonged periods of sitting and working at a computer may be required.
• Frequent collaboration via virtual meetings with cross-functional teams and external partners; must complete required safety and compliance training within allotted timeframes.
• Work is deadline-driven and may require managing multiple programs and priorities simultaneously.
• May require occasional travel (up to 10%) for key meetings, as business needs dictate.

Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.