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Description
The Creative Group has a client in need of a Regulatory Review Associate! This is an ongoing consulting assignment that will start off remotely and eventually may require going onsite in Philadelphia, PA. You will follow protocols established by pharmaceutical clients when submitting marketing materials for regulatory review. This includes preparing completed editorial content to the Medical-Legal-Regulatory (MLR) review board (a board of experts typically consisting of medical doctors, lawyers and experts in FDA regulations), submitting materials to the client (both electronically and/or in hard copy as determined by the clients' specifications), and tracking the progress of each project through the various stages of MLR review.
Responsibilities include:
Determine the time and effort required to complete each submission
Establish a timeline and assign responsibility to the appropriate team members for the delivery of the components of the submission
Create and/or oversee the creation of the components and ensure they conform to proper guidelines
Maintain a comprehensive, accurate dashboard of all current and upcoming submissions including the stage of review, job codes, and deadlines
Follow up with client liaison in a timely manner to ensure the submission is received on time and meets 100% of client expectations and specifications
Act as the primary point of contact between the agency and the clients' MLR Review department, both to get information regarding submissions requirements and to answer procedural questions that arise during the MLR review process
Create, update, and disseminate to the rest of the department procedure(s) specific to the clients supported
Qualifications include:
Minimum of a bachelor's degree and 2-4 years of experience in the preparation of complex deliverables under tight deadline constraints is required.
Technical competency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite are required.
Experience communicating with clients directly is required.
Clear communication and attention to detail are essential.
Clear, concise technical writing ability is strongly preferred.
- Experience in Pharmaceutical Industry or Healthcare is preferred.
Requirements
- Strong project planning and management tasks, business systems support functions and project costing techniques
- Having a Project Management and/or Business Systems Analyst Certification is a bonus
- Expert in project management software such as Microsoft Project, SmartSheet or other similar applications
- Project management experience desired
- Bachelor's degree in accounting or finance & Project Management Professional (PMP) Certification
- A track record of working with or in an accounting function with a key role in system projects preferred
The Creative Group (TCG), a Robert Half company, matches creative, digital and marketing professionals with some of the best companies on a freelance, project or direct-hire basis. At TCG, we understand that you have a real passion for your work, and we spend time with you from the beginning in order to assess your skills, determine your strengths and figure out the type of work you want to do. Our personalized approach, innovative matching technology and global network with local market expertise help you find the creative, marketing and digital jobs that match your skills and priorities - fast. By working with us, you have access to challenging opportunities, competitive compensation and benefits, and training to enhance your skill sets.
From philanthropy to environmental stewardship to employee programs, Robert Half is proud to have an active role in the communities in which we live and work. Our company has appeared on FORTUNE's "Most Admired Companies" list every year since 1998.
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All applicants applying for U.S. job openings must be authorized to work in the United States. All applicants applying for Canadian job openings must be authorized to work in Canada.
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