Clinigen

Compliance

• Clinigen, a rapidly growing global specialty pharmaceutical services business, is seeking a detail-oriented and motivated Regulatory Associate to join our dynamic team.
• Assist in the preparation and submission of regulatory documents
• Maintain up-to-date records
• Provide support for regulatory inquiries
• Work closely with the Regulatory Affairs team and other departments to facilitate timely delivery of projects
• Ensure all regulatory submissions are accurate and complete
• Grow career in regulatory affairs and contribute to the success of products

Regulatory Associate / Senior Associate

Operations

• Assist with the planning and coordination of daily operational activities
• Support the demand planning function by managing inventories and forecasting
• Ensure stock levels are maintained and discrepancies are addressed promptly
• Prepare and maintain accurate records and reports related to operations
• Collaborate with cross-functional teams to ensure seamless operations and communication
• Handle queries and provide support to internal teams and external stakeholders
• Assist in the implementation of operational improvements and best practices
• Participate in training and development initiatives for staff as required
• Contribute to the maintenance of a safe and compliant working environment

Operations Assistant

Procurement

• Working with international suppliers to source hard to find medicines at competitive rates
• Handling inbound unlicensed sourcing enquiries
• Pursue multiple options to achieve cost reductions e.g. negotiate rebates, exploit price breaks, mitigate cost price increases, improve payment terms etc.
• Tendering of large value product requirements where appropriate
• Establish and develop supplier and manufacturer relationships
• Leverages a detailed understanding of marketplace, competitors and business requirements
• Constructs detailed cost models/purchase price analysis of goods and services to drive the control, containment and reduction of costs for Clinigen and to provide deep and meaningful insights to the Commercial team’s
• Understanding of unlicensed product acquisition needs across the Clinigen group and taking advantage of synergies
• Performs detailed analysis of supplier proposals and payment schedules and conducts rigorous price negotiations with suppliers
• Maintain and expand global supplier base to ensure development and contribute to the global sourcing strategy
• Strategy development/implementation: Utilizes Sourcing process, other tools and techniques to create and execute RFIs, RFQs together with subsequent structured information analysis wherever possible using internal and external datasets
• Find opportunities to increase spend and portfolio of products that are sourced direct from manufacturer and ensure Clinigen Group has a commercial edge over competitors
• Review of product needs, targeting key manufacturers for direct purchasing and exclusivity
• Work with business development and commercial teams to pursue partnerships for key products
• Ongoing review of new and emerging suppliers, competitors and market dynamics at global level

Sourcing Specialist

Analyst

• Serves as a key resource for interpreting data and information; communicates results to team members
• Operates as a key contact between departments and IT to facilitate the delivery of business intelligence solutions
• Works closely with IT project managers and operations to coordinate cross-functional project activities and ensure deliverables are accurate and meet customer requirements
• Utilizes business intelligence tools across all departments and functional areas providing detailed reporting and analysis
• Assesses analytics and reporting needs; in time providing recommendations for enhanced solutions and specifications for business intelligence tools
• Supports the delivery of BI solutions to internal and external customers
• Supports prioritization of reporting needs across process areas to support deployment strategies and business needs
• Supports development of protocols to extract data in a standardized process from a variety of data sources
• Supports development and definition of data management standards and processes to effectively manage data through the reporting life cycle
• Supports data mining of customer and sales force information for all relevant market segments
• Supports development of prototypes and models for database, data integrations and data transformation needs
• Maintains and develops strong working relationships with business owners as a process advocate
• Supports creation of speech and presentation materials for members of the management team
• Keeps abreast of healthcare trends and competitor activity

Junior Analyst

Manager

• Company Responsible Person for Link Healthcare Malaysia
• Manage Sales & Marketing and Medicine Access business including Named Patient Supply (NPS), Expanded Access Programs (EAP) and registered products
• Oversee clinical trial services, medical information support and business development for portfolio expansion
• Lead product planning, product management, pricing, tender support and product launches
• Manage sales forecasts, budgets, inventory and sales reporting
• Ensure pharmacovigilance, regulatory compliance (NPRA) and quality management adherence
• Build and manage relationships with key hospital influencers and customers
• Ensure team training, customer clinical support and timely responses

Senior Market Access Manager

Customer Success Manager

• Clinigen is a rapidly growing global specialty pharmaceutical services business with over 1,000 employees and offices in the UK, US, EU, Asia Pacific and South Africa.
• Proactive, client-focused Client Engagement Manager generating sales leads for the Managed Access Division and supporting targeting, conference strategies, and digital engagement.
• Generate sales leads for Business Development against pre-defined target assets and companies; support qualification of target assets.
• Conduct client outreach via social media, telephone, email and conferences; create compelling client-specific hooks to secure direct contact opportunities.
• Identify target decision makers and work with Marketing to ensure coverage of target assets, people and companies; support Thought Leadership positioning.
• Support horizon scanning and liaison with conference organisers; support BD before and during industry conferences to drive lead generation.
• Maintain BD MA SharePoint elements and develop SME status in Salesforce use; collaborate with internal stakeholders to leverage existing Clinigen relationships.

Client Engagement Manager – Pharmaceutical

Financial Planning and Analysis

• Clinigen is a global specialty pharmaceutical and services company operating in a complex regulatory environment, ensuring vital medicines are delivered securely and on time.
• FP&A Manager will direct all commercial finance and management reporting activities across the CSM business unit.
• Lead the CSM commercial Finance Team responsible for budgeting, forecasting, internal reporting, P&L, Balance Sheet, and Cash Flow management.
• Own provision of monthly management accounts and KPIs, consolidation of global CSM results, monthly business review packs, rolling forecasts, and the annual budget and long-range processes.
• Review sales commission plans and payout calculations to ensure financial governance and quarterly commission reviews.
• Provide financial input on business or investment projects (ERP, regulatory changes, M&A, licensing deals, divestments).
• Support sales leadership with financial review of new business opportunities and RFI responses.
• Review and improve systems and processes, integrating local EU and US processes with the global finance strategy.
• Must live within 60 miles from Malvern, PA, USA.