Report Writer (entry level- science background needed)

Resolian; Malvern (Chester County); On-site; USD 80,000 - 110,000; Full time

Job summary

Resolian is a global CRO providing GLP/GCP bioanalytical and analytical services across the US, UK, and Australia. The role requires knowledge of regulatory guidelines and the ability to prepare quality study documentation and communicate findings from study data.

You will oversee the report lifecycle, address QA audits, and manage client submissions, using LIMS and other data systems while collaborating with scientific teams and adapting to changing timelines.

Qualifications

• Knowledge of GLP, GCP, 21CFR Part 11 and GDP regulations.
• Demonstrated ability to write scientifically and technically.
• Ability to work in a regulated environment and in a team.

Responsibilities

• Oversee report lifecycle and QA audits.
• Prepare data, charts, and figures for reports.
• Communicate study findings clearly to clients.

Skills

GLP/GCP standards

SOPs & Study Documents

GDP & GDP practices

Regulatory guidelines

Communication of findings

Team collaboration

Microsoft Office

Education

BA/BS in science or related field

Tools

LIMS

Microsoft Office

Job description

Resolian – Your global bioanalytical, biomarker and analytical sciences partner supporting all phases of your drug development.

Resolian is a leading global Contract Research Organization (CRO) providing specialized services in GxP and non-regulated bioanalysis, drug metabolism/pharmacokinetic (DMPK), and GMP CMC analytical and materials science. Its team of more than 400 experts across the US, UK, and Australia, Resolian supports pharma and biotech companies’ programs throughout the entire drug development continuum.

Responsibilities

• Have a good knowledge of the appropriate GLP/GCP standards and latest regulatory guidelines, to include 21CFR Part 11.
• Be familiar with, and work in accordance with, SOPs and Study Documents.
• Complete all paperwork in compliance with good record keeping principles; correctly and on time in compliance with GLP/GCP and in accordance with Good Documentation Practices (GDP).
• Prepare documents in accordance with requirements. Be able to effectively communicate findings and summaries from study data.
• Utilize LIMS and other data systems to prepare data, chromatograms, tables, and figures for inclusion in reports.
• Work with scientific teams regarding technical and study details.
• Responsible for overseeing report lifecycle, addressing QA audits, and submission of reports to clients.
• Be flexible; realise that timelines, priorities and requirements will change regularly and respond to these challenges accordingly.
• Ability to plan and organise your work, while being aware of required timelines. Manage your own time and challenge yourself to identify and champion process improvement opportunities
• Make suggestions for how processes can be improved and efficiency maximised, to include revising and/or creating report templates, lab manuals and other items as needed.

Skills, Education & Qualifications

• BA/BS in a science or related field preferred; all experiences will be evaluated
• Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP.
• Demonstrated knowledge of scientific or technical writing, with proven written skills
• Able to work in a regulated environment
• Able to work effectively and contribute within a team
• Able to work with computer systems; in-depth knowledge of Microsoft Office.