Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet Janice Worley, Vice President, Medical Writing
Describe the biggest challenge facing our clients/industry today. How are we addressing this?
One of the biggest challenges facing the industry today is navigating the mounting regulatory requirements mandating increased transparency. Clinical trial Sponsors are required to disclose much more information than ever before and often must balance multiple regulatory authority regulations. ProPharma is addressing this challenge directly by combining state-of-the-art technology with our years of industry experience to provide guidance and direct support for redaction and anonymization of all documents that may be subject to transparency directives. ProPharma's highly experienced team of redaction experts harness the power of AI and automation to help clients identify both company confidential information (CCI) and personally protected data (PPD), providing the necessary guidance and direction to client stakeholders as they review documents to ensure all data are appropriately protected.
What do you like best about working with clients?
I really enjoy helping clients tackle regulatory challenges to identify 'best-fit' solutions that meet their specific medical writing or clinical trials disclosure needs. Whether that is building a team of subject matter experts to provide "boots on the ground" support or leveraging those same subject matter experts to provide guidance as they navigate and interpret the ever-evolving regulations, I enjoy being able to leverage my years of experience to help ensure their success!
What's your number one goal / focus right now?
My number one focus right now is working with clients to develop customized solutions to meet all their medical writing and clinical trials disclosure needs. Today that means I am focusing on redaction and anonymization, helping clients to develop parameters for the protection of company confidential information as they navigate global transparency legislation. Tomorrow, that could be helping develop templates for plain language documents and providing the expertise to distill scientific content into easily readable content. Either way, my focus is on building and supporting a team of highly experienced subject matter experts that help clients achieve all their medical writing or clinical trials disclosure objectives.
What do you do at ProPharma? How does your role support improving the health and safety of patients?
My role at ProPharma as Vice President, Medical Writing involves leading a highly experienced dynamic and global team of medical writers and clinical trials disclosure (CTD) specialists and building customized solutions for clients that leverage the expertise within that team. On a daily basis, our CTD experts support activities that impact the health and safety of patients. Our ultimate responsibility is to provide clear, succinct, and non-promotional information to patients across a wide variety of therapies that can be used by patients and/or caregivers to guide and inform future treatment decisions. We understand the gravity of this role and work diligently to ensure accuracy and timeliness of all projects so that patients can confidently rely upon this information.
What value does a client gain by working with ProPharma's Clinical Trials Disclosure experts?
Clients who work with ProPharma's Clinical Trials Disclosure (CTD) experts gain the value of peace of mind, knowing that our depth and breadth of knowledge can be leveraged to help them successfully navigate the ever-evolving landscape of transparency requirements. Our global, dynamic and highly experienced team members are seasoned project managers with a laser focus on quality. ProPharma's CTD experts autonomously drive development and ensure a high-quality, compliant deliverable, allowing your team to focus on other priorities.
