For the past 20 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. As the world’s largest RCO (Research Consulting Organization), 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.
The Principal Regulatory Medical Writer drives the development of each deliverable including de novo writing (to varying levels) and/or managing stakeholder contributions, ensuring adherence to client styles and formatting, managing stakeholder expectations, and ensuring timeline integrity across a wide variety of clinical and safety document types. The Regulatory Medical Writer reports to the Vice President, Global Medical Writing FSP & Transparency Solutions/Associate Director, Medical Writing and provides support to ProPharma Clients.
Advanced degree (PharmD, PhD, Masters) within a relevant scientific discipline with a minimum 6-7 years of medical writing of clinical regulatory documents.
Represent medical writing as part of a global, cross-functional team and work independently to successfully drive the production and development of each deliverable following the client business process
Ensure adherence to GCP, ICH guidelines, SOPs, and client templates and style guides
Interpret and present clinical and scientific data
Manage contributions from multiple, global cross-functional stakeholders
Manage and communicate timelines to stakeholders
Manage the review, adjudication, and finalization (approval, publishing) of each deliverable, as applicable
Provide frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time
Develop strong, lasting relationships with client teams that encourage organic new business growth
Solid understanding of the drug development process, including the documents that are required at each stage and the roles of other functional areas and group interdependencies within research operations
Knowledge and understanding of Good Publication Practices and clinical research process, including ICH GCP and FDA regulation
Mastery of the English language and relevant scientific terminology
Exceptional written and verbal communication skills
Superior attention to detail
Project/stakeholder management
Experience working with templates and style guides
Skilled (mastery level) in the following technologies:
Microsoft Suite (Word, PowerPoint, and Excel)
Adobe Acrobat/PDF software
SharePoint
Document management systems and associated tools
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.
ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More
