ICON Strategic Solutions · 1 day ago
CMC Project Manager I EDS
US, San Antonio, TX, IDS
Full-time
Hybrid
Entry Level
1+ years expICON plc is a world-leading healthcare intelligence and clinical research organization. They are seeking a CMC Project Manager I to oversee CMC projects, ensuring smooth coordination between internal teams, sponsors, and vendors while driving project execution and compliance with global regulatory requirements.
Pharmaceuticals
Responsibilities
Lead and manage multiple CMC projects from early development through commercialization
Coordinate cross-functional teams, including Analytical, Formulation Development, Manufacturing, Regulatory, and Quality Assurance
Review and authoring of relevant method validation, pharmaceutical analysis, QC reports and other relevant GMP documentation and deliverables
Develop and maintain detailed project plans, timelines, and risk assessments
Ensure compliance with global regulatory requirements, including FDA, EMA, and ICH guidelines
Act as the primary liaison between clients, internal teams, and third-party vendors to ensure alignment and timely execution of project deliverables
Work with planning to ensure that appropriate resources are available to complete the study to timeline
Proactively identify and address potential project risks, implementing effective mitigation strategies
Provide clear, timely, and professional communication to stakeholders regarding project progress, milestones, and potential challenges
Monitor project budgets and resource allocation to ensure efficient and cost-effective project execution and draft change order budget when scope changes occur
Support regulatory submissions by providing CMC-related documentation and guidance
Qualification
Required
A minimum of 1 year experience in clinical, laboratory or project management role
Background in project management, preferably in a pharmaceutical setting
Familiarity with GMP regulations and compliance requirements
Excellent communication and interpersonal skills
Ability to effectively manage resources and prioritize tasks to meet project deadlines
Detail-oriented with strong organizational and problem-solving abilities
Preferred
Bachelor or advanced degree in a relevant scientific field preferred, e.g. medicinal chemistry, organic chemistry, pharmaceutical sciences
Benefits
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
H1B Sponsorship
ICON Strategic Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
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