$100K — $150K *
The Medical Affairs Operations Associate Director supports Medical Affairs (MA) project management and cross-functional tactical alignment to support MA strategic initiatives. This role will work closely with all MA internal stakeholders and broader R&D, legal, compliance stakeholder to ensure projects (e.g. FFS Annual R&D and Medical Plan updates, medical ad boards, Collaborative Research, medical education initiatives) are initiated and completed in a timely manner. This role will support MA cross-functional development, and management of medical plans. This role will support MA cross-functional training and communication strategies to ensure business competency and transparency is met. This role will support various R&D; Commercial and MA cross-functional quarterly, monthly, weekly update meetings.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
This position will provide cross-functional management to support successful execution of MA led initiatives. Effective and continuous collaboration with Commercial, Legal, Compliance, and Finance is required.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Medical Affairs Operation & Project Management
§ Provide project management support to Medical Directors, Medical Information, Scientific Communications (Publications), and Risk Management to ensure initiation and completion of tactical projects to support MA strategy.
§ Support Medical Directors with therapeutic area aligned MA meetings to ensure strategy is effectively communicated to all internal stakeholders.
§ Project manage the R&D Annual and Medical Plan updates in collaboration with various stakeholders from MA, R&D, Legal and Compliance to ensure compliance with tactical execution of the plans.
§ Lead cross-functional MA team to support area directors and leaders in launch plans and life cycle management strategies.
§ Assist as requested with MA and Medical Information departmental budget reviews.
Systems & Compliance
§ In collaboration with internal MA stakeholders, evaluate existing process update or support development of new process to ensure alignment with company policies, industry standards and applicable regulatory guidance.
§ In collaboration with MA leadership evaluate, support and implement all systems upgrade across MA (e.g. IRMS, Datavision, Cybergrants).
§ In collaboration with MA leadership help to develop and implement appropriate action plans in response to unexpected events (i.e., recalls).
§ Oversee the Medical Portal Governance meetings to ensure continuous improvement and compliance are met.
§ Support as requested the development and/or execution of training on relevant business policies/processes and systems and monitor Medical Affairs progress to ensure adherence with compliance programs post CIA.
§ Support as requested MA personnel at Endo and contracted external providers are properly trained to operate within U.S. regulatory requirements and company standards.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Master’s degree in Science, Health Administration, or related field professional degree (Pharmacist; Nurse) preferred.
§ 10-15 years of relevant industry experience.
§ 5 years of project management experience; Project Management Professional (PMP) certification desired.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Comprehensive understanding of the individual functions within Medical Affairs.
§ Knowledge of pharmaceutical/healthcare market, acceptable practices, relevant guidelines and regulations required.
§ Strong knowledge pertaining to Medical Affairs.
§ Knowledge of drug development and various R&D disciplines involved in overall drug lifecycle.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Proactive, self-motivated, and aware of larger business needs/implications.
§ Expert with the Microsoft Office suite of products including Excel and PowerPoint.
§ Demonstrated ability to work both independently and interdependently in cross-functional teams.
§ Exceptional written and verbal communication skills, including the ability to clearly communicate business processes and solutions.
§ Ability to collaborate in a fast-paced and evolving professional environment.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Valid through: 5/27/2021
$200K — $250K
11 days ago
$100K — $150K
11 days ago