FSP Document Review Specialist II (North America)

Work Schedule

Environmental Conditions

Job Description

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 Functional Service Partnership (FSP) Team in North America. We are seeking an experienced and skilled Document Review Specialist II who will be dedicated to one or more clients in the FSP space to join our team; experience working in a range of document management systems would be preferred. As a remote-based Document Review Specialist within the FSP Team you will effectively review regulatory documents including but not limited to submissions documents protocols and amendments clinical study reports investigators brochures and patient safety narratives to ensure quality standards and adherence to templates client guidelines editorial style guides and industry standards. You will collaborate with internal clients supporting and enabling effective communication that results in operational excellence and quality deliverables. This role requires meticulous attention to detail a high English proficiency with the ability to communicate clearly and concisely and a solid understanding of regulatory document content.

Key Responsibilities:

• Reviews highly technical scientific documents of all types developed within or outside of the company to ensure quality standards that meet or exceed client expectations.

• Verifies scientific logic and clarity of the document by verifying data in tables listings and figures 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.

Education and Experience:

• Bachelors degree or equivalent and relevant formal academic/vocational qualification required.

• Previous editorial experience that provides the knowledge skills and abilities to perform the job (comparable to 2 years).

• Experience working in the pharmaceutical/CRO industry preferred.

• If CRO experience: experience working in a client-dedicated role or with 1 to 2 clients over multiple projects is preferred.

• In some cases an equivalency consisting of a combination of appropriate education training and/or directly related editorial experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities:

• Capable of focusing on document details and the overall objectives and intent of document messaging.

• 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 requirements of the FDA and other international regulatory agencies.

• Attentive to detail and quality of documents thorough and methodical.

• Proficient oral and written communication and grammatical skills.

• Good organizational and planning skills.

• Good interpersonal skills.

• Proven ability to work effectively in a team environment.

• Advanced computer literacy and expertise.

• Good knowledge and 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 crosscultural geographically dispersed environment.

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 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 with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

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