Project Manager II

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…

ClinChoice is searching for a Project Manager II to work with one of our partner pharmaceutical companies. This is open to either a temporary employee on a 12‑month fixed‑term contract, or a freelancer.

ClinChoice is a global full‑service CRO with a strong focus on quality, professional development and supportive culture. As a client‑facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high‑trust environment with the client counterparts.

Scope of role

The Project Manager will provide comprehensive leadership, oversight, and execution support for a late‑stage pharmaceutical development program entering FDA and EMA registration. The role requires previous exposure to drug development, clinical operations, and regulatory, as well as the ability to coordinate complex activities across internal and external scientific, operational and business teams. Reporting directly to the CSO, and interacting with the Company’s senior management members, the Project Manager ensures that program deliverables are achieved on schedule and to the highest quality standards.

Main Job Tasks and Responsibilities

• Lead planning, execution, and tracking of program activities supporting the regulatory submissions (NDA/MAA) of a late‑stage pharmaceutical development program
• Define project scope, goals and deliverables
• Develop detailed project plans, schedules, budgets, and tracking tools
• Monitor project progress and adjust plans
• Manage scope, risk, resources, budgets, and deliverables across multiple functions
• Communicate project status, risks, and outcomes to stakeholders
• Manage changes to project scope, timeline, and costs
• Ensure timely preparation of documents for internal governance committees and external submissions
• Coordinate internal or external meetings, managing agenda, meeting minutes and action items

Cross‑Functional Coordination

• Facilitate structured team meetings with clear agendas, action items, decision logs, and documented follow‑up
• Serve as the common point of contact linking scientific, operational, regulatory, and quality functions
• Maintain a unified program timeline and proactively identify interdependencies, gaps, and risks across functions

Clinical Operations and Development

• Track progress of ongoing activities (e.g., statistical analyses, CSR preparation) and ensure alignment with regulatory submission timelines
• Track review cycles for clinical documents, including protocols, CSRs, SAPs, and clinical modules for the submission dossier

Non‑clinical Function

• Collaborate with Non‑clinical team scientists to manage timelines for non‑clinical study reports and integration of non‑clinical data into Module 4 for the submission dossier
• Support non‑clinical team in coordination of any bridging or additional studies requested by regulatory authorities during the review process

Pharmaceutical & Analytical Development

• Collaborate with CMC and Analytical Development teams to ensure timely completion of formulation development, analytical method validation, comparability assessments, and stability program updates
• Track progress toward critical CMC deliverables, including specifications, control strategies, stability studies, manufacturing documents (e.g., PV protocols and reports, executed MBR), and analytical documentation required for Module 3
• Coordinate cross‑functional reviews of CMC data packages and ensure alignment with Quality and Regulatory prior to submission

Regulatory Affairs

• Collaborate with the Regulatory Affairs department and external CRO(s) to keep track of submission plans, regulatory strategies, and content timelines for FDA and EMA registration
• Track preparation of briefing documents, meeting packages, submission modules, and responses to regulatory queries, ensuring all functional contributors are aligned with regulatory expectations and submission milestones
• In collaboration with the Regulatory Affairs department and external CRO(s), oversee collection, QC, and integration of cross‑functional content (e.g., reports, documents, certificates, etc.) for Modules 1–5

Manufacturing / CMC Operations

• Coordinate with internal Manufacturing and research and development team to track production campaigns, process validation activities, batch release, and supply‑chain readiness for both clinical and commercial phases
• Track API and finished product facility inspections

Governance, Reporting & Communication

• Provide regular status updates, issue summaries, and decision requests to senior leadership
• Prepare materials for executive reviews and Board‑level updates
• Maintain documentation and communication channels in compliance with quality standards

Education, Experience and Skills

• Bachelor’s degree in Pharmacy, Pharmaceutical Chemistry and Technology, Chemistry, Biology, Biochemistry, or related discipline
• >5 years of project management experience in the pharmaceutical/biotech industry
• Previous knowledge of GxP, ICH guidelines, and drug development pathways
• Demonstrated ability to manage cross‑functional teams and complex timelines
• Demonstrated excellent proficiency in English, both written and oral
• Advanced scientific or technical degree (MS, PharmD, PhD, MBA)
• Direct experience with registration‑phase programs and FDA/EMA submissions
• PMP or equivalent PM certification
• Experience with CRO management and global teams
• Strong leadership and facilitation skills
• Excellent organizational, analytical, and problem‑solving capabilities
• Ability to work effectively in a dynamic, fast‑paced, high‑growth environment
• High integrity and commitment to quality and compliance

ClinChoice is an equal‑opportunity employer.

Key words: Project Manager, FDA/EMA registration, CMC (Chemistry, Manufacturing, and Controls), Drug development, Clinical Operations, Regulatory, CRO, Contract Research Organisation, Outsourced, Pharmaceutical, Pharma.

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