Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
At Thermo Fisher Scientific, you will 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.
Summarized Purpose:
We are excited to be expanding our Medical Writing FSP Team in NA. We are looking for an entry-level writer to join our team. The successful applicant will assist with the development of high-quality clinical and regulatory documents from planning and coordination through to delivery of final drafts, ensuring they meet all regulatory requirements and company standards. They will collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
Key Responsibilities:
- Assists with researching, writing, and editing routine documents including narratives, clinical study reports, and study protocols, and summarizes data from clinical studies.
- May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- Assists with ensuring compliance with quality processes and requirements for assigned documents.
- May assist in program management activities. Duties could include assisting with developing timelines, budgets, and forecasts.
- Participates in 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 required; Advanced degree preferred.
- Previous experience that provides the knowledge, skills, and abilities to perform the role (comparable to 0 to 2 years).
- Experience working in the pharmaceutical/CRO industry advantageous.
- Experience in scientific writing advantageous.
Knowledge, Skills, and Abilities:
- Basic 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.
- Basic knowledge of regulatory documentation and drug development process.
- Good judgment and decision-making.
- Competent computer skills and use of templates; basic knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
What We Offer:
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
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 a flexible working culture, where PPD clinical research services truly value a work-life balance. We have 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. 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.
