Principal Medical Writer (Regulatory MW)
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Job Location:
Morrisville, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
10 days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Principal Medical Writer
At Thermo Fisher Scientific youll 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.
Our Medical Writing team is growing and we are looking for a Principal Medical Writer. This role is based in the United States.
Discover Impactful Work:
Lead ambitious initiatives that craft the future of clinical research. Your expertise will enable us to deliver flawless Regulatory Medical Writing documents such as protocols CSR Investigator Brochures and Marketing Applications ensuring outstanding quality and compliance.
A Day in the Life:
- 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.
Keys to Success:
- Acts with intensity
- Strong project management skills
- Excellent interpersonal skills including problem solving and negotiation
- Able to perform a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Education
- Bachelors degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
Experience
- 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.
Knowledge Skills Abilities
- 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
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
What We Offer:
As well as being rewarded a competitive salary we have an extensive benefits package based around the health and well-being of our employees. We have aflexible working culture where PPD clinical research services truly value a work-life balance. Weve grown sustainably year on year but continue to offer a collaborative environment with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain5 reasons to work with us. As one team of 100000 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 at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.
Required Experience:
Staff IC
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
