Job Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Job Description
:
This position will be responsible for project management activities around developing and implementing restricted substances management (RSM) regulatory requirements such as EU REACH, US Conflict Minerals, US Prop. 65, EU Restriction of Hazardous Substances (RoHS), etc.
Responsibilities:
- Independently organize, develop, implement, and manage assigned aspects of existing- and Client RSM chemical regulatory projects. This includes outlining scope, time and resource management, communications, and risk mitigation throughout the project.
- Assigned aspects include interpreting regulatory requirements, creating an actionable business process, implementing the process, and demonstrating necessary compliance.
- Handle several small to medium size projects in parallel and/or assist on larger projects Develop, track, and communicate progress against program milestones and deliverables.
- Interacts internally, across multiple functional areas, and externally, with Suppliers and Third Party Manufacturers, to obtain restricted substances supporting data to justify business and regulatory needs. Data must be well-organized and stored within existing client systems.
- Ensures RSM compliance is considered as part of long-term and short-term planning, including lifecycle management and new product introduction.
- Reviews and analyzes component and sub-assembly information, assessing for restricted substances impact.
- Works collaboratively with appropriate organizations to facilitate RSM implementation and compliance through the communication of RSM issues and development of process and tools.
Requirements:
- Bachelor's degree, preferably in science/engineering discipline or related technical field.
- Minimum 1-2 years demonstrated project management experience.
- Proven leadership ability, demonstrated initiative and excellent communication skills.
- Self-starter able to work with minimal supervision; results oriented; strong workload organization- and problem-solving skills.
- Knowledge of today's key global restricted substances regulations (e.g. EU RoHS, EU REACH); familiarity with pharmaceutical R&D, pharma manufacturing/TPM, and supply chain activities.
- Demonstrated team player with ability to work collaboratively with RSM team and functional counterparts in a global environment; ability to influence and solicit cooperation (internally and externally) to meet program objectives.
- Strong program management skills and techniques (i.e. plans, schedules, presentations, etc.).
- Competency with Microsoft software suite (e.g. PowerPoint, MS Word, Excel, Outlook).
Top 3-5 skills:
- Can work independently with minimal guidance.
- Proactive/strong initiative with ability to manage multiple programs in parallel.
- Strong written and oral communication skills.
- Demonstrate project management capabilities.
- Technical skills to interpret and apply chemical regulations requirements to client products.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Job Tags
Contract work, Temporary work, Immediate start,