- Aequor (Thousand Oaks, CA)
- …management of staff. 2. May perform or oversee the following functions: a) Review and approve product MPsb) Approve process validation protocols and reports for Mfg. ... group. Ability to evaluate documentation/ operations according to company and regulatory guidelines Ability to interact with regulatory agencies. Demonstrate… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for ... research studiesExecution, and close out of primary data collection, chart review , database, and molecular epidemiology studies in addition to other… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately ... system#LI-HC1#IND-123Eisai Salary Transparency Language:The base salary range for the Senior Manager , Medical Writing is from :126,300-165,800Under current… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Senior Specialist provides expertise in the coordination of resources and equipment pertaining to qualification/validation activities ... supporting the vaccine expansion facility. Primary Responsibilities: The Quality Senior Specialist will be responsible for comprehensive management of all activities… more
- Lundbeck (Chicago, IL)
- …journey of growth!Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager Sales Training and Development is primarily responsible for ... sales management training needs by observing individual Biopharmaceutical Account Manager performance/behaviors and collaborating with the appropriate functional areas… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... low to medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, data surveillance review ,… more
- Merck & Co. (North Wales, PA)
- …scientist on a clinical trial team.Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with ... related study materials (eg, ICF documents/amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …principals and ensure all projects and materials have been through the correct regulatory review process before being delivered to field sales forces.Support ... & Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director level in sales, sales training, and marketing… more
- Insmed Incorporated (Bridgewater, NJ)
- …monitoring remediation, and support in developing guidance documents and training. The Manager , US Compliance reports to the Senior Director, US ... fun? Yes? Then maybe you will be our next Manager of US Compliance! This role will implement day-to-day...Speakers Bureau program, including but not limited to the review of program materials, oversight of Speaker selection process… more
- Aequor (Thousand Oaks, CA)
- …environment. The Capital Projects Sourcing Manager will report to the Category Senior Manager for Capital Construction and have the opportunity to work ... - EST or CST time zone preferred. CANDIDATES MUST COMPLETE THE PRESCREENING QUESTIONS FOR REVIEW ON RESUME: (1) How many years have you work on the planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... specifications as per CDISC SDTMIG.Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams.Develop,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functions, as well as building a network with key staff members including senior management, the global functional leads, Regulatory Intelligence, and Policy and ... around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining ... materials that pertain to training objectives for use at Senior Leadership meetings.Special Projects/Change ManagementAssist the Director in the implementation… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …site. Relocation assistance is available for selected candidate. Relationships Reports to: Senior Manager - Facilities Engineering & Metrology. Number of ... local departments. multiple international production sites Support the creation and review of documentation (Specifications, SOPs, etc.) in accordance with local, NN… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo, ... overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That strategy will… more
- Publicis Groupe (New York, NY)
- …clients) follow the protocol established by our pharmaceutical company clients for regulatory review . The Senior Manager plays a key role in establishing ... for identifying and solving potential issues across their account(s). Additionally the Senior Manager , Regulatory Review must traffic, manage and assign… more
- Publicis Groupe (New York, NY)
- …and effort required to create various components of each submission for a Manager , Regulatory Review or Senior Associate, Regulatory Review + ... Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Associate, Regulatory Review works closely with the internal… more
- Scotiabank (New York, NY)
- Senior Manager , Regulatory Technology **Requisition ID:** 198629 **Salary Range:** 110,700.00 - 211,800.00 _Please note that the Salary Range shown is a ... every future! **Purpose** This role will serve as a Senior Manager in the Technology Governance Office,...auditors on tracking remediation action plans. + Draft and review regulatory responses; provide oversight, feedback, and… more
- STERIS (St. Paul, MN)
- Senior Manager , International Regulatory Affairs Biocides - Remote Req ID: 41369 Job Category: Regulatory Affairs St Paul, MN, US, 55102 Description: At ... Utilizes electronic record-keeping tools according to departmental policy. The Senior Regulatory Affairs Manager is...for use are appropriate and cleared indications for use. Review and approve product literature. + Apply regulatory… more
