Project Manager II at Clinchoice

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 counter-parts. 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: Project Management & Operational Execution • Lead planning, execution, and tracking of program activities supporting the regulatory submissions (NDA/MAA) of a late-stage pharmaceutical development program, including: • 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 Liaises with core internal and external functions involved in the project, ensuring coordination, efficient communication, and coherent program execution: • 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. Will help coordinate the activities of following 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. Nonclinical Function • Collaborate with Nonclinical team scientists to manage timelines for nonclinical study reports and integration of nonclinical data into Module 4 for the submission dossier. • Support nonclinical 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 in ensuring 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. • Tracks the 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. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Project Manager, FDA/EMA registration, CMC (Chemistry, Manufacturing, and Controls), Drug development, Clinical Operations, Regulatory, CRO, Contract Research Organisation, Outsourced, Pharmaceutical, Pharma. #LI-CM1 #LI-TEMPORARY