Open Position
Title: Associate Director of Medical Information and Operations
Location: Remote
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
Role
The Associate Director of Medical Information and Review will be responsible to lead and manage the operational and tactical execution of TG Therapeutics’ Medical Information capability. Additionally, this role will have shared responsibility to represent medical affairs in the TG Therapeutics’ Medical Legal Regulatory (MLR) review process.
Key Responsibilities
Responsibilities:
––In conjunction with the Executive Director, Medical Operations, develop TG Therapeutics’ Medical Information capability including, but not limited to, coordinating call center activity with the selected agency, developing Standard Response Documents, product FAQs, appropriate safety and pharmacovigilance reporting procedures, and Medical Information Responses, both standard and non-standard.
––Lead and manage the execution of the Medical Information plan across the product portfolio of investigational and, if applicable, marketed products
––Ensure alignment of the Medical Information capability with the medical affairs strategy, including implementation of best practices and long-range strategic planning and the development of policies, procedures, and templates
––Create standard responses and FAQs for rapid and consistent dissemination of product data across multiple regions
––Create and update database of responses including frequency of use, need for non-standard response, and other metrics to guide medical affairs strategy development for education, and field medical prioritization
––Create and oversee seamless interface with pharmacovigilance to document and respond to all safety queries and adverse event reports in line with regulatory requirements in all required regions
––Actively participate in MLR process to review materials for external and internal use to ensure medical accuracy of content
––Collaborate with the Director of Scientific Communications to ensure timely training of all medical affairs staff members on new Medical Information resources, processes, and procedures
––Provide regular med info updates to all internal stakeholders and serve as the internal expert on all TG Therapeutics’ med info metrics, queries, and responses
––Conduct literature searches and interpret scientific literature for internal stakeholders, including competitor assessments and gap analysis assessments
––Manage vendors and budgets to execute on agreed-upon tactics and projects often executing on multiple projects simultaneously
––Maintain a thorough understanding of disease biology, scientific data, and competitive data in order to develop scientifically rigorous and high-quality products and programs
––Other responsibilities within medical affairs may be assigned
––Working with the legal and compliance develop SOP for TG Medical Information practices
––Implement and oversee the execution of a Medical Information platform that meets industry standards and is able to pass all regulatory audits
Principal Responsibilities Summary:
––Responsible for development and implementation of a med info plan for the all products and disease indications
––Creation of database of standard response documents and FAQs
––Compliantly create non-standard responses to appropriate medical information queries
––Work with Pharmacovigilance to ensure documentation of all reported safety queries and adverse events, as well as company response
––Analyze, interpret, and summarize scientific and clinical data to ensure up to date medical information resources and training materials
––Participate in MLR process to ensure medical accuracy of all reviewed content
Professional Experience/Qualifications
––5-7 years’ experience in pharmaceutical industry
––Strong familiarity of Medial Information processes, resources, and regulatory requirements
––Experience with promotional review and medical review processes
––Strong Scientific background necessary. PhD, PharmD, or other relevant advanced degree a plus
––Multiple Sclerosis experience preferred
––Ability to work with teams and/or agencies to plan, write and develop standard response documents, FAQs, internal training documents, med info letters, and other resources
––Ability to interact and communicate openly and effectively with senior leadership, external key opinion leaders, and commercial and development team members
––Demonstrated ability to work independently
––Ability to interpret and organize highly complex scientific data, including experience reviewing clinical trial data and output from statistical analysis programs
––Experience working closely with KOLs
––Strong analytical skills, especially with regard to understanding and interpreting scientific and clinical research and literature are essential
––Must have strong project management skills and ability to successfully manage multiple assignments on time with high quality
––Advanced computer and Internet skills, including knowledge of MS applications such as Word, PowerPoint, and Excel; PubMed; Reference databases
––Adept, nimble, energetic and comfortable in a fast-paced, dynamic and collaborative environment
––Capable of taking a hands-on approach and willing to “roll up one’s sleeves.”
––Provide MI coverage for all MS congresses ( in person travel US and International) for AAN, CMSC, ACTRIMS, EAN, ECTRIMS and possibly Charcot congress.
Education
Advanced Clinical/Science Degree required (e.g., MD, PharmD, PhD, MSN, NP, PA etc.)