Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders, and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

What makes this opportunity truly exceptional is the chance to contribute to world-class research in a dynamic and ambitious environment. As Senior Scientific Writer, you will play a crucial role in communicating scientific data to our clients. Your writing skills and proven ability to distill complex information into clear and accurate content will be instrumental in providing quality deliverables to our clients in support of drug development.

Summarized Purpose:

Prepares and reviews scientific documents under general supervision to meet or exceed quality standards. Writes, edits and reviews moderately complex to complex methods, protocols and reports for potential submission to regulatory authorities.

Responsibilities:

- Prepares and/or assists in the preparation of scientific documents such as methods, protocols, reports, method development summaries, analytical methods, SOPs, client correspondence and other similar documentation.

- Compiles laboratory data into a specified report format. Ensures that hardcopy and electronic reports are consistent and comply with required formats. Reviews data tables and listings and ensures that errors are corrected. Performs a quality control review of review of scientific documents prior to creation of the final pdf deliverable. Ensures compliance with PPD, Client, eCTD policy and procedure on publications.

- Reviews scientific documents for accuracy, formatting, consistency and compliance to protocols or SOPs.

- Interacts with laboratory to determine format of scientific documents.

- Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents.

- Performs other duties as assigned.

Qualifications:

Education and Experience

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

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years') or equivalent combination of education, training, & experience.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, Abilities:

- Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts

- Good knowledge of word processing, spreadsheets, table and graph generation and use of applicable computer software

- Knowledge of regulations, ICH, and compendial requirements of the pharmaceutical industry

- Working knowledge of analytical laboratory procedures

- Effective written and oral communication skills

- Detail oriented

- Time management skills

- Strong editorial and proofreading skills

- Proven problem solving and troubleshooting abilities

- Ability to work well in a collaborative team environment

Working Conditions and Environment:

- Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.

- Occasional drives to site locations, occasional domestic travel.

- Exposure to biological fluids with potential exposure to infectious organisms.

- Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.

- Personal protective equipment required such as protective eyewear, garments and gloves.

- Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements:

- Ability to work in an upright and /or stationary position for 6-8 hours per day.

- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.

- Occasional mobility needed.

- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

- Frequently interacts with others to obtain or relate information to diverse groups.

- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.

- Performs 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.

- Regular and consistent attendance.

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.

Apply today! http://jobs.thermofisher.com

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.

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