PharmaEssentia

QA Engineer

• Lead the development and maintenance of the PV Quality Management System (QMS).
• Ensure compliance with global regulatory requirements (FDA, EMA, MHRA) and ICH-GCP/ICH-E2E guidelines.
• Oversee PV audits, inspections, and readiness activities with PV vendors.
• Collaborate with CRO vendor, QA, Regulatory, and Clinical teams to implement corrective and preventive actions (CAPAs).
• Develop, review, and approve Standard Operating Procedures (SOPs) and work instructions for PV activities.
• Monitor key quality and compliance metrics, identify risks, and recommend mitigation strategies.
• Provide guidance and training to PV staff on quality standards and compliance expectations.
• Collaborate with cross-functional teams (Clinical, Regulatory, Medical Affairs, and Operations) to maintain high-quality safety processes.

Associate Director, Pharmacovigilance Quality & Compliance

Director

• Assess training needs for selling skills, product knowledge, competitive knowledge, and business acumen
• Develop and lead product-specific and market-specific training programs and materials in conjunction with Sales Leadership, Marketing, Market Access and Analytics teams, ensuring alignment with brand strategy and contribution to sales performance
• Partner with subject matter experts across the organization for training content
• Determine the appropriate mix of training vehicles, such as: web-based, home study, classroom
• Develop assessment tools to validate and document learning and proficiency
• Represent/navigate training initiatives as necessary through Medical Legal Regulatory Committee (MLR) approval process
• Work collaboratively with the Sales Leadership team to establish standards and coordinate delivery of PEC’s training program for new hires and existing members of the field sales organization and internal commercial teams
• Conduct field rides with members of field sales organization to provide in-the-field coaching, assess training needs, and evaluate training effectiveness and document observations and coaching steps via Field Coaching Report
• Evaluate and improve program effectiveness through assessment tools, defined KPIs, testing and user feedback; continually seek and support new approaches, practices, and processes to improve the efficiency of training services offered
• Support the development of cross-functional training workshops and programs, including product launch, New Hire, POA, and national business meeting

Associate Director, Commercial Training

Account Manager

• Responsible for all sales activities in an assigned geographical area to maximize sales achievement for BESREMi®
• Build and execute strategic territory plans across stakeholders involved in patient care to educate customers about BESREMi® and drive adoption
• Promote PharmaEssentia products to approved, targeted customers and distribution channels
• Engage hematologists/oncologists, nurses, pharmacists, pharmacy and therapeutics groups, teaching institutions, hospitals and formulary committees
• Communicate the clinical profile of BESREMi®, describe pivotal trial data and address clinical and non-clinical barriers to adoption
• Partner with cross-functional commercial partners such as market access and medical teams to provide comprehensive solutions for customers
• Develop specific account/prescriber action plans using analytics to track progress against goals
• Meet and exceed business objectives through planning, collaboration, and flawless execution of strategic direction
• Utilize CRM as a strategic tool for assessing and tracking customer status and progressing sales plans
• Complete sales administrative requirements (T&E, compliance SOPs, Sunshine reporting, etc.)
• Become a subject matter expert on disease state knowledge, clinical acumen, product expertise, competitive intelligence, and local market access

Hematology Account Manager

• Identify and integrate the unmet needs and perspectives of healthcare providers, payers, patients, and caregivers into product and franchise Medical Affairs strategies
• Strategic development and overall accountability and tactical execution of our flagship product ropeginterferon launch in polycythemia vera
• Collaborate cross-functionally as well as collaborate with external KOLs and decision-makers
• Lead the PharmaEssentia platform and product portfolio specific Medical Affairs strategy and execution
• Develop, execute and collaborate a highly efficient, integrated US medical affairs/scientific strategy
• Provide management and oversight of the Medical Affairs team which includes the US HEOR team, publication and scientific communication team, call center, Congress planning and KOL mapping and strategy
• Scientific evidence generation (RWE, HEOR, Phase IV and IIT) and scientific information exchange with all key stakeholders
• Involvement in the planning, strategy, tactics, slide deck development, and training of the MSL team; strong collaboration with the MSL director
• Provide cross-functional support to MSLs, medical information, regulatory affairs and clinical development with medical and scientific expertise for life cycle management
• Review and approve medical and scientific content of Regulatory, Safety, Medical Affairs, and Commercial
• Partner with stakeholders to develop and implement real world evidence generating strategies for assigned programs and provide subject matter expertise
• Provide Strategic Guidance / US PEC representation at corporate meetings & events
• Serve as Launch Lead/MSL Lead; engage External Experts (Providers, Payers, Advocacy)
• Support Clinical Development and study-site engagement, and identify and manage relationships with key stakeholders

Senior Director, Medical Affairs

• Oversee development, implementation, and management of pricing strategies and compliance reporting related to government healthcare programs (Medicare, Medicaid, 340B)
• Responsible for data preparation, validation, calculation, and analytics related to administration of government and commercial contracts
• Analyze, document, review, and submit mandated product and pricing obligations (AMP, BP, USA, state reporting, PHS, NFAMP, FCP, FSS, IFF, TRICARE) within mandated timelines
• Develop, implement, maintain and approve key controls ensuring compliance and timely government program submissions (AMP, BP, ASP, nFAMP, PHS, FCP, state reporting)
• Collaborate with 3rd party partners responsible for state price transparency reporting and government pricing
• Maintain government pricing methodologies, SOPs and reasonable assumptions per federal statutes and regulations
• Work with Accounting and Commercial functions to analyze rebate and chargeback data for government pricing calculations
• Provide meaningful analysis on government pricing issues to support business decisions and commercial strategies
• Monitor government pricing regulations and market conditions to inform reimbursement and access strategies
• Partner with senior leadership and cross-functional teams on commercial/pricing changes assessing compliance and financial implications
• Support Accounting with documentation, calculations, and memos for period-end closes
• Provide proactive and reactive analytics to improve Forecasting, Contracting, Pricing Decisions, Business Planning & divestiture deals
• Provide input and recommendations on proposed and new Government Regulations and drive continuous process improvement

Associate Director, Pharmacovigilance Quality & Compliance

Associate Director, Commercial Training

Hematology Account Manager

Senior Director, Medical Affairs

Associate Director, Government Pricing and Reporting