OWP Pharmaceuticals

Compliance

• Responsible for on-time filing of high-quality regulatory submissions
• Preparation and review of ANDAs, NDAs, annual reports, periodic adverse events reports, supplements, amendments
• Reviews and manages regulatory submissions to FDA from international partners and CMOs
• Review and approve CMC and Labeling change controls
• Familiar with FDA requirements and ICH
• Adhere to submission timelines
• Administration and management of assigned products
• Serve as the primary regulatory interface with US FDA manufacturing partners and internal teams
• Support Biosimilar BLA/PAS/CBE submissions

Senior Associate, Regulatory Affairs – CMC

Accountant

• Assists in month end close process, including revenue, inventory, fixed assets, prepaids and supply chain accounting, reconciliation and analysis.
• Analyzes, processes and resolves chargebacks items to establish appropriate credit within the contractual requirements through extensive research of EDI submissions to resolve discrepancies between wholesaler requests for credit and the Meitheal chargeback system.
• Performs corporate accounts payable and accounts receivable functions.
• Reviews results on a monthly basis and provides variance analysis.
• Prepares and maintains accounting documentation, including technical accounting research on complex accounting issues and documents the position papers.
• Independently and timely perform non-recurring, one-off projects and other analyses as delegated by the Associate Director of Accounting.

Senior Accountant, Pharmaceuticals

Vice President

• Provides leadership to the National Accounts and Trade teams and across the organization, while fostering a culture of teamwork, accountability, professional development and high-performance.
• Develops robust, detailed, and structured performance goals & objectives.
• Identifies growth and development opportunities for team members and provides measurement & reporting tools for key performance indicators.
• Provides insight on GPO, Alternate Site, 340B/Apexus, IDN customer channels, Specialty Distributors, and the wholesaler distribution channel, as well as competitive intelligence and emerging trends in the industry.
• Leverages external relationships to enhance strategic partnerships and company profitability.
• Provides leadership and direction to the team in obtaining pertinent information that supports Meitheal’s go-to-market strategies.
• Coordinates and leads effective internal and external business meetings with clear, direct communication and decision-making.
• Supports day-to-day activities of the National Accounts and Trade teams, and provides leadership to ensure effective communication, sales positioning, contracts strategy, and negotation efforts are implemented that support achieving both individual and company goals.
• Presents internal and external recommendations on business opportunities to drive growth in support of Meitheal’s overall business objectives.
• Works cross functionally with Marketing/Product Management, Contract Marketing, Pricing and Legal to develop effective strategies for contract/product offers, bid processing, Terms & Conditions language, and post award compliance tracking.
• Collaborate with executive leadership and present internal/external recommendations on business opportunities in support of team and company goals.
• Supports solution development efforts that best address team and organizational needs, while coordinating the involvement of all necessary company personnel.
• Support the achievement of strategic objectives critical to other functional areas within the organization.
• Promotes the Meitheal Culture through positive interpersonal interactions.
• If this is not located in the Corporate office, regular travel to the Corporate office will be required.
• Other duties, as assigned.

Vice President, National Accounts – Trade

• Support, prepare, and review communication documents & submissions to the agencies, including controlled correspondences, FDA meeting packages (Pre-ANDA, Pre-IND, BIA, BPD2/3/4, etc.), and submissions (IND, NDAs, ANDAs, BLA)
• Address complex and technical issues with solid scientific rationalization, with or without supervision
• Identify and act on issues and risks from regulatory perspective, especially for complex generics and biosimilars
• Provide regulatory assessments to the company (internal and partners), including change controls and/or document changes based on ICH and FDA guidelines
• Track deficiency trends and develop proactive and/or mitigation measures accordingly

Senior Associate, Regulatory Affairs – CMC & Reg. Sciences

• Provide regulatory guidance to product development
• Support and review CMC sessions in submissions & deficiency responses
• Manage the regulatory aspects of products and projects
• Prepare and review communication documents & submissions to the agencies, including IND, BIA, BPD2/4, BLAs, etc.
• Track and interpret FDA new guidance & new requirements and assess their impact on product development
• Represent the regulatory function on cross-functional developmental teams primarily with Operation, Quality, Legal and Marketing groups
• Provide training on regulatory sciences within RA department and cross-functions

Senior Manager, Regulatory Affairs – CMC, Reg. Sciences

Product Manager

• Develops and maintains an understanding of assigned product portfolio, including current and future market trends, landscape, customer mix and competitors.
• Supports all short-term planning through commercial forecasts and budget activities.
• Develops recommendations and brings forward key decisions needed from Senior Management in support of short and long-term financial goals for our product portfolio.
• Actively works with Finance and Pricing teams to track financial performance and identify and recommend strategies to amplify successes and mitigate gaps.
• Provides pricing recommendations to help maximize product sales and gross profits.
• Identifies opportunities for increasing market share by assessing competitive landscape and patient needs.
• Assists with completion of product and supply chain information for RFIs, RFPs, and bid documents, as well as corporate strategy documents.
• Responsible for accurate forecasting and tactical execution of plans to mitigate financial risks for the category, including but not limited to, allocation/trade-off analyses, discussions, decisions and short-dated product risks.
• Go-to person for national accounts, sales, trade relations and contract marketing for product attribute information, product availability, sales collaterals, RFI completion and other internal data sources.
• Works with manufacturing, supply chain, and customer service to ensure accurate and timely sales forecasting for new and existing products, including performing a monthly analysis versus marketing forecast to manage variances and participate in pre-S&OP process.
• Partners with Sr. Director Product Management to provide support and development of analysis and presentations to senior management for creation and reporting of short- and long-term financial plans.