- May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- Ensures compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods and techniques for achieving optimal results.
- May assist in program management activities. Duties could include assisting with developing timelines, budgets, forecasts for assigned deliverables.
- Represents the department at project launch meetings, review meetings, and project team meetings.
- Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
- Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
- Exercises judgement within defined procedures and practices to determine appropriate action.
- Contacts are primarily internal to the company with infrequent external customer / vendor contact on routine matters.
- Builds productive internal / external working relationships.
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years).
- Be able to carry out basic project work independently with minimal coaching.
- Experience working in the pharmaceutical/CRO industry preferred
- Experience in scientific writing.
- Solid medical writing skills, including grammatical, editorial, and proofreading skills
- Ability to interpret and present complex data accurately and concisely
- Effective administrative, organizational and planning skills; attention to detail and quality
- Ability to work on own initiative and effectively within a team
- Effective oral and written communication skills
- Good knowledge of regulatory documentation and drug development process
- Great judgment and decision-making skills
- Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)
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Medical Writer - Shanghai, 中国 - Thermo Fisher Scientific
描述
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.
In Biostatistics and Programming, we are passionate about data and technical agility to drive enhanced value for our customers and patients. Determined to improve patient health, we provide statistics, programming and clinical pharmacology expertise through global delivery, consistent quality adherence and scientific insight. Through a procedural framework based on robust planning and specifications, we deliver clinical trial planning and development programs, results of a study and lead the regulatory submissions.
Discover Impactful Work:
Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results. 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.
A day in the Life:
Keys to Success:
Education
Experience
Knowledge, Skills, Abilities
Working Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
