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
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries
Requirements
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification; Advanced degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years)
- Experience in managing and directing complex Regulatory medical writing projects required
- Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
- 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); willingness to utilize technology to support authoring efficiency
Responsibilities
- Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients
- 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
- May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
- As an essential advisory member of the writing team, may 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
- May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications
Skills
Medical Writing
Regulatory Writing
Clinical Study Reports
Study Protocols
Investigator Brochures
INDs
MAAs
Clinical Research
Scientific Writing
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
