Principal Regulatory Medical Writer
2 semanas atrás
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Principal Regulatory Medical Writer (home based)**
As a Principal Medical Writer, you will serve as the primary author by writing and providing input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
You will be a part of a team who is dedicated to its people and fosters a supportive, collaborative culture based on trust, flexibility and work-life balance. You would be able to consider the work setting where you would be most productive, able to choose being entirely remote based or work part-time of at least 25-30hours per week.
**Summarized Purpose**:
**Essential Functions**:
- Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
- Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
- Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes.
- May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
- Represents the department at project launch meetings, review meetings, and project team meetings.
**Education and Experience**:
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
- Experience within regulatory medical writing (comparable to 8+ years).
- Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
- _In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered enough for an individual to meet the requirements of the role._
**Knowledge, Skills and Abilities**:
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Excellent project management skills
- Advanced interpersonal, oral and written communication, and presentation skills
- Excellent negotiation skills
- Excellent judgment; high degree of independence in decision making and problem solving
- Ability to mentor and lead junior level staff.
**Our 4i Values**:
**Integrity - Innovation - Intensity - Involvement
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