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Associate Director, CMC Program Management Direct Hire MA
Job ID: 15215 Direct Hire MA
Global Pharmaceutical company here in the Metro-West area of MA is seeking an Associate Director, CMC Program Management! This role will be a part of the Global R&D Operations and has responsibilities for the development, coordination and delivery of high-quality CMC dossiers in a timely manner for all small and large molecule based pharmaceutical and biopharmaceutical products from First in Human clinical studies to Market Authorization Applications.
Associate Director will be a part of a group consisting of industrial scientists and regulatory CMC professionals. This group provides the expertise and guidance to all aspects of CMC dossiers throughout the product development cycles. In collaboration with the CMC and regulatory CMC teams, it develops dossier development strategies, execution plan and coordinates with CMC functional areas for the final delivery of high-quality CMC dossiers in full alignment with the project milestone objectives and timelines. It anticipates, proposes and develops regulatory solutions for CMC technical challenges during the product development cycle. It serves as liaison to closely align the global support with the CMC dossier needs, interfaces and ensures full alignment globally within the company and with external business alliance partners.
- Have product development CMC experience and technical expertise, with Biologics, to understand and support the CMC dossier function and manage pipeline products CMC dossiers for regulatory filing, agency communication and registration approval of clinical trial applications as well as market authorizations.
- Ensure seamless submission of CMC Dossiers for assigned projects in development for clinical studies, registration and approval, emphasizing scientific content and quality consistent with current & evolving regulatory requirements and expectations.
- Liase with the CMC teams including the regulatory CMC organizations to bring/interpret agency queries to the global team and with agency on behalf of the global team to address agency questions for successful regulatory submissions and approvals.
- Be responsible for executing the assignments and ensuring timely delivery of quality dossiers and communication.
- Undergraduate (e.g., bachelor) or an advanced graduate degree (e.g., Ph.D.) with background in the fields of biomedical sciences such as biology, biochemistry, protein chemistry, bio-engineering.
- 5+ years of experience for an undergraduate degree holder or 3 years for a graduate degree holder in Biologics R&D development experience in pharmaceutical/biotech industry and/or regulatory agencies with emphasis on CMC development or regulatory CMC.
- Worked in CMC development organizations or regulatory agencies with expertise in product development, registration and demonstrated accomplishments in product development and CMC filings.
- Understanding of entire R&D processes and state-of-the-art approaches in biologics, notably in the CMC development area. Expertise and experience in one or more of the following areas: bio-research, bio-development including process development, analytical development and/or formulation development and/or GMP bio-manufacturing.
- Biologics CMC dossiers fluency. CMC dossiers include, but not limited to, clinical study applications (IND/IMPD/CTA), market authorization applications (BLA/NDA/MAA) and regulatory documents for major product development milestone regulatory agency meetings, inspections and written responses to CMC related questions. Successfully delivered CMC dossiers for regulatory submissions
- Regulatory working knowledge from operational and project perspective (submissions, inspections, approvals), for major modalities such as mAbs.
- International experience (international assignments and/or multinational projects & teams)
Marketing Project Manager | Integrated | In-house Direct Hire MA
Job ID: 15163 Direct Hire MA
Our client, a leader in the payments space, is seeking a Project Manager to join their team. You will be responsible for the scheduling and workflow of projects and campaigns for the global marketing team. In this role you will manage the planning process, direction, and coordination of project timelines and deliverables for multiple projects simultaneously from conception through completion.
- Work with marketing communications and digital management to reassign projects/tasks as needed to ensure timeliness and meeting deliverables
- Organize and facilitate status reports, project initiation, proofing and project update meetings, providing actionable feedback necessary for project completion
- Work with outside vendors and agencies, internal partners and external freelancers; source new vendors when needed
- Maintain and publish planning calendars, schedules and reports for marketing teams to aid in workflow efficiency and timeliness
- Estimate when projects may be running off track/agreed-upon schedule and communicate escalation issues to relevant stakeholders/management
- Create, organize, and distribute marketing deliverable, campaign and project briefs and SLAs; update as needs change over time
- Monitor on-going resource tracking, timeline adjustments, and project and workflow trends, with a deliverable of providing quarterly reporting
- Bachelor’s degree in Marketing, Business, Communications or related field
- Experience with workflow or project management tools and MS office applications
- 5+ years in traffic/project coordination position in a fast-paced, high-volume environment
- Strong knowledge of creative and digital best practices
- Ability to adapt well to changing priorities and react quickly
- Effective problem-solver and negotiator of deadlines and deliverables