Senior Manager, Clinical Medical Writer
Bristol-Myers SquibbSalary not specified
[Remote] Principal Medical Writer (Regulatory MW) at Thermo Fisher Scientific
North Carolina, United States
Not SpecifiedCompensation
N/AExperience Level
N/AJob Type
Not SpecifiedVisa
N/AIndustries
Requirements
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification; Advanced degree preferred
- 8+ years of relevant experience
- Experience managing and directing complex Regulatory medical writing projects
- Experience working in the pharmaceutical/CRO industry preferred
- Significant knowledge of global, regional, national, and other document development guidelines
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, marketing application submissions, communications, etc
- Strong project management skills
- Excellent interpersonal skills including problem-solving and decision-making
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g., Excel, Outlook)
Responsibilities
- Lead ambitious initiatives that craft the future of clinical research
- Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients
- Serve 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
- Research, write, or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
- Provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development strategy, document types, regulatory requirements, and industry best practices
- Assist in program management activities, including developing timelines, budgets, forecasts, and contract modifications
Skills
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
