Objective

• Define and drive the medical writing strategy in alignment with corporate and regulatory goals, ensuring high-quality scientific and regulatory documents.
• Provide senior-level leadership in the development of clinical trial protocols and reports, ensuring regulatory compliance and scientific rigor.
• Leads strategic document preparation for INDs, NDAs, MAAs, briefing documents, and responses to regulatory inquiries.
• Establish best practices, workflow infrastructure / templates, and standards to enhance consistency and quality across all regulatory and scientific documents.

• Oversee the development and finalization of high-quality, scientifically accurate, ICH compliant documents, including clinical study protocol and reports, Investigator Brochures, Periodic Safety Updates, patient narratives, and manuscripts for peer-reviewed publications.
• Ensure alignment with regulatory guidelines and corporate objectives in the preparation of critical regulatory documents.
• Drive consistency, accuracy, and scientific integrity in all medical writing deliverables.

• Ensure all written materials meet regulatory standards, company SOPs, and project-specific requirements.
• Develop and implement quality control measures to enhance document accuracy, clarity, and compliance.
• Stay abreast of global regulatory requirements and guidelines (FDA, EMA, ICH, etc.), ensuring company compliance and best practices.
• Lead initiatives to improve medical writing processes, efficiency, and cross-functional communication.

• Serve as a recognized subject matter expert in oncology medical writing, keeping current with scientific advancements and regulatory trends.
• Represent the medical writing function at internal and external meetings, including regulatory interactions, industry conferences, and advisory boards.
• Provide strategic guidance and mentorship to junior and mid-level medical writers, fostering professional development and technical expertise.

• Partner with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and pharmacovigilance, to ensure seamless integration of medical writing into drug development processes.
• Lead and oversee medical writing project timelines, ensuring alignment with broader corporate milestones.
• Cultivate a culture of collaboration, excellence, and innovation within the medical writing team.

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 Science, Medical, or Science Communication, or a related field; PhD preferred.
• Minimum of 12 years of experience in medical writing, with a strong emphasis on oncology and regulatory writing.
• Experience with CoAuthor or alike is preferred
• Proven track record of leading medical writing strategy and delivering high-quality regulatory documents, including clinical trial protocols, regulatory submissions, and scientific communications.
• Experienced in interactions with regulatory agencies and guiding teams through the submission process.
• Strong leadership experience, with the ability to manage and mentor teams.
• Proficiency in Microsoft Office suite, document management systems, and electronic publishing tools

• Ability to provide strategic oversight while managing multiple priorities in a fast-paced environment.
• Deep understanding of ICH-GCP guidelines and other relevant regulatory requirements.
• Exceptional written and verbal communication skills, with a keen eye for detail and accuracy.
• Strong cross-functional leadership skills, with the ability to collaborate effectively across teams.
• Strategic thinker with strong execution skills, capable of influencing decision-making at senior levels.
• Adaptability to a dynamic, fast-growing company environment.
• Must be willing to travel up to 10% of the time.

Work Environment

• May be required to sit or stand for long periods of 8+ hours a day while performing duties. 
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.

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

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.