Transparency and Public Disclosure Associate (m/f/d)

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

What the job looks like
Each day you'll enjoy a variety of challenges, such as:

• Coordinate resourcing of all activities related to clinical trial data sharing, publication of lay summaries, and redaction of trial documents according to global regulations by overseeing these activities internally and/or managing selected vendors for Grunenthal’s portfolio
• Liaise with clinical study teams, patent attorneys, corporate communications, and other pertinent stakeholders to ensure timely and accurate information is reviewed/approved prior to public release
• Remain up to date on Global Regulations and plan, coordinate, and prepare for internal process changes needed and provide presentations/guidance to ensure knowledge transfer to R&D team members
• Collect and share knowledge on changes in trial disclosure requirements and industry’s best practices 
• Liaise with multiple vendors to ensure consistent reporting across Grunenthal’s portfolio. Act as the subject matter expert during regulatory inspections
• Develop, review, and approve SOPs, guidelines, or work instructions
• Participate in training and educational opportunities for personal development and cross-training within the organization
• Other projects or tasks such as medical writing support, review of medical writing documents may be assigned by company management
• Act as a back-up for other functions within Medical Writing and Public Disclosure when required

What you’ll bring to the table
To make the most of this role and truly thrive, you should have:

• BA or BS plus 5+ years or Master’s degree plus 3+ years of experience in Transparency and Public Disclosure activities 
• Strong knowledge of the life science industry 
• Has familiarity with US FDA, ICH/GCP, and European Regulatory Authority requirements as applicable to a study (or other countries where a study is conducted)
• Strong analytical and problem-solving skills 
• Ability to learn quickly and adapt to system and technology changes 
• Proficient in Microsoft Office, Adobe Acrobat, SharePoint, and clinical systems
• Professional, proactive attitude 
• Strong interpersonal skills, obtaining buy-in without authority and leading with purpose 
• Excellent written and verbal communication skills

This is a part-time position of 80%.