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Director, Global Medical Communication, Oncology

3 months ago

Seattle, United States Perspective Therapeutics Full time
Job DescriptionJob DescriptionObjective
Reporting to the Chief Medical Officer, the Director, Global Medical Communications will lead and mentor a team to develop and execute comprehensive communication strategies for Perspective Therapeutics’ oncology products.  S/he will oversee seamless coordination of medical information content, new indication launches, and promotional reviews while driving the conversion of text-only documents into visually enhanced materials.  In the early stages of the role, s/he will streamline internal processes, implement best practices, and develop alliances with business partners for international product launches.  This role will be instrumental in developing and executing communication strategies for Perspective’s oncology portfolio and ensuring the highest standards of medical content dissemination.

Essential Functions
  • Protocol Development: Lead and contribute to the development of clinical trial protocols for oncology studies, ensuring alignment with regulatory guidelines and scientific integrity.
  • Regulatory Submissions: Prepare and review regulatory documents such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), briefing documents, and responses to regulatory authorities.
  • Scientific Writing: Produce high-quality, scientifically accurate documents including clinical study reports (CSRs), investigator brochures (IBs), patient narratives, and manuscripts for publication in peer-reviewed journals.
  • Quality Assurance: Ensure all written materials meet regulatory standards, company SOPs, and project-specific requirements. Conduct thorough reviews and edits to maintain accuracy, consistency, and adherence to timelines.
  • Cross-functional Collaboration: Collaborate effectively with cross-functional teams including clinical development, regulatory affairs, biostatistics, and pharmacovigilance to gather information and ensure alignment on project objectives.
  • Therapeutic Expertise: Serve as a subject matter expert in oncology, staying abreast of current literature, industry trends, and regulatory guidelines. Provide guidance and mentorship to junior medical writers as needed.
  • Compliance and Training: Maintain knowledge of global regulatory requirements and guidelines (FDA, EMA, ICH, etc.) relevant to oncology drug development. Participate in training sessions and contribute to process improvements to enhance efficiency and quality in medical writing operations.
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 Science, Medical or Science Communication, or a related field.  PhD preferred.
  • Minimum of 8 years of experience in medical writing, with a strong emphasis on oncology.
  • Proven track record in preparing clinical trial protocols, regulatory submissions, and other oncology-specific documents.
  • Proficiency in Microsoft Office suite and familiarity with document management systems and electronic publishing tools.

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.

Knowledge / Skill / Ability
  • Ability to work independently and collaboratively in a fast-paced environment, managing multiple priorities effectively.
  • Excellent understanding of ICH-GCP guidelines and other relevant regulatory requirements.
  • Exceptional written and verbal communication skills, with a keen eye for detail and accuracy
  • Ability to build cross-functional relationships and work collaboratively.
  • Ability to think strategically and execute.
  • Flexibility and comfort level with ambiguity in a small company environment.
  • Must be willing to travel up to 10% of the time.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

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.

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