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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.)