医学撰写人 - 临床法规文件
Medical Writer - Clinical Regulatory Documentation
目标
向医学/法规撰写主管汇报，医学撰稿人——临床法规文件将负责准备和交付高质量、科学准确且符合法规要求的临床/医学文件，以支持临床开发和法规提交。该职位将与跨职能团队合作，撰写临床/法规文件，包括方案、临床研究报告（CSRs）、研究者手册（IBs）以及IND/CTA、NDA/MMA和其他法规文件的临床模块。
主要职责
- 医学撰写：撰写清晰、简洁且科学准确的临床文件，包括但不限于临床方案、临床研究报告（CSRs）、研究者手册（IBs）、临床试验文件，以及法规提交的模块（IND、NDA/MMA等）。
- 跨职能协作：与临床开发、法规事务及其他相关方（如非临床、CMC等）紧密合作，确保所有医学撰写成果符合项目目标、时间表和法规要求。
- 法规合规：确保所有文件符合适用的全球法规要求（如FDA、EMA、ICH指南），并遵守内部标准和最佳实践。
- 文件审查与修订：根据内部相关方和外部监管机构的反馈，参与临床文件的审查与修订。确保文件结构合理、准确，并符合监管期望。
- 质量保证：协助保持所有临床文档的高质量标准。确保所有书面材料的一致性、准确性和科学严谨性。
- 项目支持：在临床开发的各个阶段提供医学撰写支持，包括早期试验、后期临床试验和法规提交。在既定时间表内管理文件的准备。
- 知识管理：及时了解相关的科学文献、法规指南和行业趋势，以指导撰写工作，确保文件反映最新的标准和最佳实践。
任职资格
***** 对于此职位，我们优先考虑有直接为申办方或CRO工作的申请人。目前我们不考虑顾问来满足我们的需求 ****
· 5-8年的医学撰写经验，
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Objective
Reporting to the Head of Medical/Regulatory Writing, the Medical Writer – Clinical Regulatory Documentationwill be responsible for the preparation and delivery of high-quality, scientifically accurate, and regulatory-compliant clinical/medical documentation to support clinical development and regulatory submissions. This role will collaborate with cross-functional teams to author clinical/regulatory documents, including protocols, clinical study reports (CSRs), investigator brochures (IBs), and clinical modules for INDs/CTAs, NDAs/MAAs, and other regulatory documents.Essential Functions
- Medical Writing: Author clear, concise, and scientifically accurate clinical documents, including but not limited to clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), clinical trial documents, and Modules for regulatory submissions (INDs, NDAs/MAAs, etc.).
- 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 regulatory requirements.
- Regulatory Compliance: Ensure all documents are in compliance with applicable global regulatory requirements (e.g., FDA, EMA, ICH guidelines) and adhere to internal standards and best practices.
- Document Review and Revision: Participate in the review and revision of clinical documents based on feedback from internal stakeholders and external regulatory bodies. Ensure that documents are well-organized, accurate, and aligned with regulatory expectations.
- Quality Assurance: Assist in maintaining high-quality standards for all clinical 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 regulatory submissions. 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.
- Familiarity with global regulatory requirements for clinical documentation (e.g., FDA, EMA, ICH).
- Strong understanding of clinical trial processes and regulatory submissions, including preparation of clinical protocols, CSRs, investigator brochures (IBs), and clinical modules for INDs, NDAs/MAAs.
- 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.
- Experience with writing for regulatory submissions (INDs, NDAs/BLAs/MAAs) 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 regulatory submission management platforms (e.g. Veeva Vault).
- Regulatory Expertise: Strong understanding of global regulatory requirements for clinical trials and medical documentation (e.g., FDA, EMA, ICH).
- 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.
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.
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: .
Originally posted on Himalayas