For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Essential Functions:
Performs detailed QC review of clinical and regulatory documents, tables, publications, annual reports, literature summaries, submission sections, internal documents, etc.
Verifies content to ensure accuracy and integrity of all factual statements within document text compared to post-text sources cited and interprets clinical data/literature as needed to perform QC duties.
Copyedits documents to correct and streamline grammar, spelling, punctuation, style, and format, while troubleshooting functionality and presentation of documents and templates.
Leads resolution of discrepant findings within documents, including documenting actions, verifying implementation of findings, and archiving results.
Project management - ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities and demands.
Works on special QC projects and initiatives to help drive consistency and performance of the QC team regarding best processes/practices, adherence to style guides, and sponsor expectations.
Key contributor to the development of process improvement tools and the development or revision of internal policies and procedures affecting QC work and processes.
Trains new hires and junior colleagues within the QC group and functions as a mentor.
Provides QC training to members of the global medical writing team in aspects relative to their roles.
Acts as a primary backup to team members during peak volume periods or to provide coverage.
Represents the QC group on study teams and on cross-functional project teams as needed.
Other duties as assigned.
Necessary Skills and Abilities:
Pharmaceutical and/or Biotech background strongly preferred.
Strong copyediting, data integrity review, accuracy, and problem-solving skills.
Exceptional time management skills and attention to detail.
Knowledge of FDA and EU requirements, ICH regulations, and ISO standards as applicable to regulatory documents.
Possesses knowledge of AMA Manual of Style.
Independently motivated and proactive.
Ability to work with minimal supervision on multiple assignments with set deadlines.
Excellent use of English language (read, write, and speak fluent English).
Expertise in Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe/PDF software.
Exceptional written and oral communication skills (reading, writing, editing, team communication).
Educational Requirements:
Bachelor’s degree in relevant field of study.
Experience Requirements:
At least 3 years of QC/editing experience in the pharmaceutical industry.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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