Document Review Spec Ii

2 weeks ago

Remote, India Thermo Fisher Scientific Full time

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.

**Discover Impactful Work**:
Effectively reviews documents created within or outside of the company to ensure quality of a standard that meets or exceeds client's expectations. Documents include: regulatory submissions, integrated clinical study reports, serious adverse event narratives, study protocols and publications. Ensures integrity of data in tables against source documents. Instructs others outside of the quality review group on the review process.

**A day in the Life**:

- Reviews highly technical documents of all types created within or outside of the company to ensure quality standard that meets or exceeds client's expectations.
- Verifies scientific logic and clarity of the document by verifying data in tables against source documents, checking for consistency according to current regulatory standards and guidelines.
- Edits for accuracy, consistency and grammatical correctness
- Adjusts schedule to accommodate unexpected requests for priority review.
- Revises scientific language for usage, flow, clarity, and audience appropriateness.
- Proactively queries authors to ensure compatibility with unique preferences and scientifically sound judgment.
- Maintains, communicates and applies knowledge of current guidelines, templates and industry standards

**Keys to Success**:
**Education**:

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification

**Experience**:

- Previous experience reviewing regulatory documents (CSRs, Clinical Protocols, ICFs, etc.), comparable to 2+ years, required.

**Knowledge, Skills, Abilities**:

- Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document's message
- Good knowledge of the methods, techniques, and procedures of medical writing tasks
- Strong analytical ability
- Good working knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g., ICH), and requirement of the FDA and other international regulatory agencies
- Detail oriented, thorough and methodical
- Proficient grammatical and communication skills, both oral and writtenGood organizational and planning skills
- Proven ability to work effectively in a team environment
- Advanced computer literacy and expertise
- Good understanding of document management systems
- Capable of working well under pressure and remaining motivated
- Capable of working both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment

**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

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Accessibility/Disability Access**:

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