FSP Senior Scientist-Scientific Writer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Sr. Scientist
- Scientific Writer This is a fully onsite role based at our customer’s site in Collegeville, PA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Key Responsibilities:

• Author validation and sample analysis reports for PK, Immunogenicity and biomarker endpoints
• QC and address comments from document review meetings
• Retrieval of all finalized bioanalytical CRO reports from teams and upload to Veeva regulatory vault.
• Publish reports in Veeva vault
• Address any questions from the Veeva publishing team, as needed.
• Cross-link of all finalized bioanalytical reports from Veeva Reg Vault to Veeva study TMF.
• Update Quickbase report listing when reports are finalized, with Veeva links and up-versioning.
• Conduct TMF completeness checks at required intervals during studies
• Provide study related document listings for m271 and integrated summary of immunogenicity

Basic Requirements:

• BS degree with 4+ years of experience, MS with 2+ years of experience, PhD with 0-2 years of experience in an appropriate subject area
• Medical Writing experience with authoring bioanalytical reports (PK, Immunogenicity, Biomarkers)
• Preferred experience with bioanalytical reporting for pharmacokinetic (PK) and immunogenicity studies within a CRO or pharmaceutical environment.
• Has good knowledge of GCP requirements and policies
• Preferred experience with Microsoft Office, Adobe and Veeva Vault

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