ERGOMED

Clinical Research

• Responsible for the design, analysis, and/or interpretation of clinical studies
• Act as the study lead for multiple studies, clinical programs, and/or large/complex studies
• Support the review and development of clinical programs
• May involve oversight of the statistical programming activities
• Ensure work is performed on time and of high quality
• Provide review and oversight to statistical output created by other members of the biostatistics department

Principal Biostatistician

Manager

• Strategically support and lead the development of proposals, including support strategy development and leading TCs
• Ensure proposal input obtained from a variety of stakeholders, typically involving contributions from sales, marketing, operational teams, finance, legal and top management
• QC and sense check of stakeholder feedback
• Ensure high quality client-focused proposals, budgets and client grids are delivered for new business opportunities
• Attend department meetings including global RFP Triage, P&C internal meetings, and other adhoc calls
• Support and Participate at Proposals training which includes the onboarding of new staff as well as ongoing training of existing staff as well as personnel outside the P&C team
• Support in activities related to coordination, development, negotiation and execution of client contracts and change orders for key accounts and key opportunities
• Support the development of Standardized procedures on a departmental level, and support in streamlining processes on proposal preparation and efficient turnaround timelines
• Support the development of junior staff by organizing lessons learned and continued education programs to optimize team performance and growth
• Support process improvement initiatives that result in the development of costs and proposals of the highest accuracy and effectiveness
• Ensure Senior Management are appropriately involved in QC and contribution to Key Opportunities and their strategies are effectively communicated to the client
• Ensure continuous departmental process improvements and participate in special projects periodically assigned, in addition to day-to-day duties

Proposals Manager – Pharmacovigilance

People Operations

• Support the delivery of key strategic HR initiatives and priorities, in close collaboration with the Chief People Officer
• Prepare high-quality materials to support decision-making (presentations, summaries, analysis, talking points)
• Track progress of key initiatives and ensure visibility and alignment across stakeholders
• Support coordination and follow-ups across strategic projects (without owning full project management responsibility)
• Support People integration activities following acquisitions, with a focus on cultural alignment and employee experience
• Assist in mapping and aligning HR processes, policies, and practices across entities
• Collaborate with HRBPs and operational teams to enable smooth employee transitions
• Contribute to initiatives that strengthen organizational culture, engagement, and ways of working
• Support cultural diagnostics and development of targeted action plans. Support development of clear, structured, and engaging communication materials
• Support People data alignment and system harmonization activities
• Contribute to reporting, insights, and analysis to support data-driven decision-making
• Ensure accuracy and consistency of documentation and outputs

People Integration – Strategic Projects Associate

Compliance

• Prepare and manage marketing authorization (MA) submissions, including the preparation of local administrative documents, quality control (QC), and compilation.
• Provide ad hoc regulatory advice on submission packages in the post-authorization stage of the medicinal product lifecycle.
• Review and provide linguistic input for local Product Information and Mock-ups.
• Serve as the primary contact point for regulatory affairs (RA) matters with national competent authorities (NCAs) and/or clients.
• Involvement in project management of the network of local contact persons for Regulatory affairs.
• Collect, process, and manage regulatory intelligence to keep the organization informed of key updates and changes.
• Propose marketing authorization strategies tailored to client needs.
• Act as a deputy for the line manager when required, ensuring seamless continuity in leadership and operations.

Senior Specialist, Regulatory Registration and Compliance

Medical writer

• Responsible for medical writing including: PSURs/PBRERs PADERs ACOs DSURs RMPs
• QC and review of all written output from the operations team as required
• Supporting the project managers to determine scheduling of the aggregate reports for which they are responsible
• In conjunction with the Quality, Compliance and Training Manager identify areas for improvement and address via training, clarifying changes to SOPs/OGs/templates
• Complete quality documentation of aggregate reports
• Attending kick off meetings with new clients as required
• Attending audits and inspections as required
• Providing aggregate report training

Medical Writer II

• Act as Local Contact Person for Pharmacovigilance for the designated country
• Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates
• With the help of a senior member of the team, develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs and core documents)
• Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures
• Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
• Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
• Ensure correct training assignment to and training compliance by the LCPs
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
• Prepare client’s invoices and review/approve vendors’ project invoices
• Provide training, coaching and mentoring to junior members of staff
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required
• Track LCPs' key performance indicators and prepare monthly summary reports
• Provide feedback on performance of vendors to aid their assessment
• Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.

Principal Biostatistician

Proposals Manager – Pharmacovigilance

Proposals Manager – Pharmacovigilance

Proposals Manager – Pharmacovigilance

Proposals Manager – Pharmacovigilance

People Integration – Strategic Projects Associate

Proposals Manager – Pharmacovigilance

Senior Specialist, Regulatory Registration and Compliance

Medical Writer II

Specialist, Regulatory & PV Delivery