- Prometheus Federal Services (Silver Spring, MD)
- …(PFS) is a trusted partner of federal health agencies, is seeking a Project Manager with consulting experience supporting the Food and Drug Administration ... and is passionate about driving meaningful transformation in public health. As a Project Manager , you will lead high-impact initiatives that support FDA… more
- General Dynamics Information Technology (Silver Spring, MD)
- …(GDIT) is seeking a detail oriented, customer-focused, and motivated **Functional Software Project Manager ** with strong communication skills that is interested ... in becoming part of our **Food and Drug Administration ( FDA )** team, supporting our customers with their critical mission...customers with their critical mission needs. The Functional Software Project Manager will be working with the… more
- Charles River Laboratories (Bethesda, MD)
- …work history and education are added correctly. **Job Summary** We are seeking a Project Manager 1 (husbandry) Bldg 35 for our Insourcing Solutions site located ... Bethesda, MD. The following are responsibilities related to the Project Manager 1: + Review, comprehend and...development of 80% of the drugs approved by the FDA for the past 3 years. **Equal Employment Opportunity**… more
- Charles River Laboratories (Bethesda, MD)
- …and education are added correctly. **Job Summary** We are looking for a Cagewash Manager to join our Insourcing Solutions team, located in Bethesda, MD. In the CWM ... The following are minimum requirements related to the Cagewash Manager position: + AA in Animal Science or a...development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories… more
- Fujifilm (Washington, DC)
- **Position Overview** The LEAD PROJECT TEAM SUPPORT ENGINEER-MI provides remote technical, applications and system support for HCUS customers and supported business ... units on the proper use of backend applications the project team manages. + Maintains an expert working knowledge...needs to have a supervisory decision made when a manager is not available. + Engineers must have the… more
- Sumitomo Pharma (Washington, DC)
- …a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the Senior Manager of ... publishing, distribution, and archiving of health authority submissions. The Senior Manager will oversee the activities of external publishing staff contracted to… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Manager , Manufacturing Technical Operations (MTO)** **Summary:** _Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... of life-enhancing and life-saving treatments for patients annually._ _Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Manager , Commercial Operations** Catalent Cell and Gene Therapy is looking to recruit **a Manager of Commercial Operations** to join our growing team in ... vaccines & hard-to-express recombinant proteins and oncolytic viruses. Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Charles River Laboratories (Rockville, MD)
- …a career that you can feel passionate about. **Job Summary** The Proposal Manager will be responsible for creating customized proposal documents for prospective and ... existing clients. The Proposal Manager works alongside commercial operations, business development, and technical...estimates, and pricing required for a robust and strategic project proposal * Qualify bids and scopes of work… more
- Grifols Shared Services North America, Inc (Washington, DC)
- …of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing ... products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical… more
- Charles River Laboratories (Bethesda, MD)
- …you can feel passionate about. **Job Summary** We are seeking an experienced Facility Manager II to join our Insourcing Solutions team, located in Bethesda, MD. As ... the Facility Manager II, you will be the primary point of...records, charts, logs, and inventories. + Actively interact with Project Officers, facility veterinarian(s) and investigators to solve customer… more
- Charles River Laboratories (Bethesda, MD)
- …feel passionate about. **Job Summary** We are seeking an experienced Assistant Facility Manager to join our Insourcing Solutions team, located in Bethesda, MD.As the ... Assistant Facility Manager , you will use existing SOPs and quality assurance...cage change scheduling, and supplies + Actively interacts with Project Officers, facility veterinarian(s) and investigators to solve customer… more
- V2X (Reston, VA)
- …with V2X's core enterprise resource planning (ERP) systems. The ERP Manager collaborates with cross-functional teams while managing vendor relationships to ensure ... deliverables. + Coordinate with internal teams and external vendors to ensure project success. + Ensure system reliability, performance, and compliance with business… more
- Sumitomo Pharma (Washington, DC)
- …. **Job Overview** The Senior Manager , Pharmacovigilance Scientist serves as the ... strategies preferred. + Experience preparing safety reports and submissions to FDA , EMA, and/or other regulatory authorities. + Effective working skills in… more
- Arena Technical Resources, LLC (Rockville, MD)
- …seeking a Senior Appian Developer in Rockville, MD to join our team supporting the FDA . The Food and Drug Administration ( FDA ) is the federal agency responsible ... food supply, cosmetics, and products that emit radiation. The FDA is also responsible for: advancing the public's health...performance issues, etc. - Work closely with the release manager to ensure completion of key tasks including deployment,… more
- United Therapeutics (Silver Spring, MD)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... holidays) on a rotational basis + Participation in Change Manager Role on a rotational basis + Excellent written...medical industry compliance regimes and controls a plus (ie FDA 21CFR 11, HIPAA/HITECH) + Present ideas and information… more
- Bayer (Washington, DC)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... strategic partnership and collaboration with territory cross-functional stakeholders (ie Area General Manager , Area Business Unit team, Field DGOS, etc.) as part of… more
- Fujifilm (Washington, DC)
- …on systems within a service area as directed by the Area Service Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to ... Performs other duties as assigned by the Area Service Manager . + Comply with all applicable US Food and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Integra LifeSciences (Columbia, MD)
- …and records with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO ... allocation and alignment of personnel in order to successfully complete project assignments. + Create site procedures for microbiological testing and sampling… more