Job Description
Objective
Reporting to the Head of Medical/Regulatory Writing, the Medical Writer - Scientific Communications will be responsible for the development and oversee vendors, as needed, for creation of high-quality scientific content. This role will collaborate with cross-functional teams for the development of global medical communications resources for use both internally and externally.
Essential Functions
- Medical Writing:
- Lead the development and maintenance of the scientific lexicon for assigned products.
- Lead the development and maintenance of scientific platforms for assigned products.
- Partner with subject matter experts (SMEs) to develop and manage scientific content for global conferences.
- Lead the development of abstracts, posters, slide decks, manuscripts. core training and educational materials, as needed
- Document and track agreed-upon medical materials as part of annual planning to ensure timely delivery.
- Support the development of medical education materials that address identified educational gaps while maintaining compliance with all internal and external requirements.
- Cross-Functional Collaboration: Work closely with clinical development, regulatory affairs, and other stakeholders (e.g., nonclinical, CMC etc) to ensure that all medical writing deliverables meet project objectives, timelines, and internal and external requirements.
- Document Review and Revision: Participate in the review and revision of documents based on feedback from internal and external stakeholders. Ensure that documents are well-organized, accurate, and aligned with internal and external expectations.
- Quality Assurance: Assist in maintaining high-quality standards for all scientific documentation. Ensure consistency, accuracy, and scientific rigor in all written materials.
- Project Support: Provide medical writing support across various stages of clinical development, including early-phase studies, late-stage clinical trials, and nonclinical and CMC teams as needed. Manage the preparation of documents within established timelines.
- Knowledge Management: Stay current with relevant scientific literature, regulatory guidelines, and industry trends to inform writing and ensure documents reflect the latest standards and best practices.
Qualifications
***** For this position, we are prioritizing applicants that have worked directly for a sponsor or CRO. We are not considering consultants to meet our needs at this time ****- Experience of 5-8 years in medical writing within the pharmaceutical, biotechnology, or clinical research industry. Experience in oncology therapeutic area is highly preferred.
- Strong scientific communications expertise with demonstrated experience developing impactful scientific materials
- Ability to manage multiple writing projects simultaneously and meet deadlines while maintaining high-quality standards.
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
- A minimum of a Bachelor’s degree in a life sciences discipline (e.g., Pharmacology, Pharmaceutical Sciences, Biology, or related field). A Master’s or Ph.D. is preferred.
- At least 5-8 years of experience in medical writing, with hands-on experience inauthoring clinical documents for regulatory submissions. Experience in oncology therapeutic area is highly preferred.
Knowledge / Skill / Ability
- Writing Skills: Excellent written and verbal communication skills with the ability to convey complex scientific information clearly and concisely for a variety of audiences.
- Tools: Experienced with standardized writing templates (e.g. StartingPoint or alike) and submission management platforms (e.g. Veeva Vault).
- Attention to Detail: Exceptional attention to detail and a commitment to producing accurate, high-quality documents.
- Collaboration: Ability to collaborate effectively with cross-functional teams, including clinical, regulatory, and other departments, to produce high-quality documentation.
- Scientific Knowledge: In-depth understanding of clinical research and scientific concepts to ensure that clinical documents are scientifically accurate and reflect the latest research findings.
- Time Management: Strong organizational and time management skills, with the ability to manage multiple projects and meet deadlines in a fast-paced environment.
- Problem-Solving: Ability to proactively identify and address challenges related to document quality, clarity, and regulatory requirements.
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: .
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