Sr. Mgr/Assoc. Dir., Marketing 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.
Organizational Overview
TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit www.tgtherapeutics.com.
Role
The Senior Manager / Associate Director, Marketing Operations, reports directly to the Executive Director of Marketing and holds a critical commercial role. This role will be responsible for managing the Medical, Legal, Regulatory Review process in support of promotional and educational content approvals to ensure business needs are met in a compliant, efficiently organized, and collaborative way. This role may also lead cross functionally the print, fulfilment, inventory management, and distribution coordination.
Key Responsibilities
• Partner with key internal and external stakeholders across the TG (MS) commercialization team to ensure a collaborative, compliant, and efficient MLR review process
• Lead the facilitation and organization of our weekly cross functional MLR meetings, ensuring stakeholder and business needs are being addressed according to project timelines
• Support each stakeholder team with annual MLR forecasting for content approvals across training, marketing, market access and medical affairs
• Proactively partner with team during offline content reviews to monitor and document progress
• Manage documentation, clarity and reconciliation of content review and approval comments
• Plan and manage weekly MLR meeting agendas across the teams to meet content approval needs and deadlines
• Monitor timelines to ensure pre-meeting documents have been distributed or routed to the MLR review team according to process timeline requirements to support an efficient use of scheduled meeting / review time
• Facilitate, in partnership with appropriate stakeholders, the delivery of approved materials for Veeva CRM upload, print production, Compliance Wire, etc.
• Continuously ensure content approvals are following the appropriate review /approval paths and document retention guidelines
• Prepare and manage 2253 submissions to the FDA, working closely with regulatory and submission vendor
• Collaborate with MLR stakeholders to solicit feedback for improving the MLR process effectiveness
• Serve as Veeva PromoMats administrator assisting with system administration responsibilities including but not limited to dashboard setup, reporting, and quality control of data integrity
• Serve as lead Veeva PromoMats administrator with the execution of MLR stakeholder training to ensure internal teams and agency partners are knowledgeable, competent, and certified in their responsibilities to successfully execute the MLR process
• Serve as Veeva PromoMats system administrator in the development of defining and reporting KPIs
• Potential to collaborate cross functionally the print, fulfilment, ordering, and distribution process to help with planning and ongoing management
• This role may also assist with select marketing projects such organization of advocacy walk/bike events where we have a live presence and booth/tent presence
• Management of contracted proofreader including prioritization of workload, approving time- cards and providing feedback on quality of work
Professional Experience/Qualifications
We are looking for an individual that is highly motivated, solutions oriented and a proactively collaborative partner with the relevant experiences in managing the MLR stakeholders and responsibilities listed above. We value someone who has exceptional communication skills and can adapt to challenging and/or changing MLR stakeholder needs to successfully support the business.
• Strong facilitation and communication skills in managing MLR stakeholder collaboration
• Expert listening skills and ability to probe for undisclosed information
• Capable of engaging with senior management and external agency partners
• Demonstrated experience in successfully supporting brand launches through the MLR process
• Working knowledge of FDA regulations, pharmaceutical advertising submission guidelines and timelines to facilitate promotional and educational content approvals
• Highly organized with exceptional attention to detail
• Experience in working with various MLR technical and organizational tools
• Experience proofreading technical documents
• Ability to build, manage, and lead multiple cross-functional partnerships and initiatives simultaneously
Education
• Associates Degree with 5+ years of relevant MLR career experience within the pharmaceutical industry
TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.
Apply Now
Apply Now
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
Organizational Overview
TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit www.tgtherapeutics.com.
Role
The Senior Manager / Associate Director, Marketing Operations, reports directly to the Executive Director of Marketing and holds a critical commercial role. This role will be responsible for managing the Medical, Legal, Regulatory Review process in support of promotional and educational content approvals to ensure business needs are met in a compliant, efficiently organized, and collaborative way. This role may also lead cross functionally the print, fulfilment, inventory management, and distribution coordination.
Key Responsibilities
• Partner with key internal and external stakeholders across the TG (MS) commercialization team to ensure a collaborative, compliant, and efficient MLR review process
• Lead the facilitation and organization of our weekly cross functional MLR meetings, ensuring stakeholder and business needs are being addressed according to project timelines
• Support each stakeholder team with annual MLR forecasting for content approvals across training, marketing, market access and medical affairs
• Proactively partner with team during offline content reviews to monitor and document progress
• Manage documentation, clarity and reconciliation of content review and approval comments
• Plan and manage weekly MLR meeting agendas across the teams to meet content approval needs and deadlines
• Monitor timelines to ensure pre-meeting documents have been distributed or routed to the MLR review team according to process timeline requirements to support an efficient use of scheduled meeting / review time
• Facilitate, in partnership with appropriate stakeholders, the delivery of approved materials for Veeva CRM upload, print production, Compliance Wire, etc.
• Continuously ensure content approvals are following the appropriate review /approval paths and document retention guidelines
• Prepare and manage 2253 submissions to the FDA, working closely with regulatory and submission vendor
• Collaborate with MLR stakeholders to solicit feedback for improving the MLR process effectiveness
• Serve as Veeva PromoMats administrator assisting with system administration responsibilities including but not limited to dashboard setup, reporting, and quality control of data integrity
• Serve as lead Veeva PromoMats administrator with the execution of MLR stakeholder training to ensure internal teams and agency partners are knowledgeable, competent, and certified in their responsibilities to successfully execute the MLR process
• Serve as Veeva PromoMats system administrator in the development of defining and reporting KPIs
• Potential to collaborate cross functionally the print, fulfilment, ordering, and distribution process to help with planning and ongoing management
• This role may also assist with select marketing projects such organization of advocacy walk/bike events where we have a live presence and booth/tent presence
• Management of contracted proofreader including prioritization of workload, approving time- cards and providing feedback on quality of work
Professional Experience/Qualifications
We are looking for an individual that is highly motivated, solutions oriented and a proactively collaborative partner with the relevant experiences in managing the MLR stakeholders and responsibilities listed above. We value someone who has exceptional communication skills and can adapt to challenging and/or changing MLR stakeholder needs to successfully support the business.
• Strong facilitation and communication skills in managing MLR stakeholder collaboration
• Expert listening skills and ability to probe for undisclosed information
• Capable of engaging with senior management and external agency partners
• Demonstrated experience in successfully supporting brand launches through the MLR process
• Working knowledge of FDA regulations, pharmaceutical advertising submission guidelines and timelines to facilitate promotional and educational content approvals
• Highly organized with exceptional attention to detail
• Experience in working with various MLR technical and organizational tools
• Experience proofreading technical documents
• Ability to build, manage, and lead multiple cross-functional partnerships and initiatives simultaneously
Education
• Associates Degree with 5+ years of relevant MLR career experience within the pharmaceutical industry
TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.
Apply Now
Apply Now