...around rare diseases and immune disorders.
Summary
The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA)... ...Coordinate GRA's data strategy with broader corporate IT projects and objectives
Collaborate with Corporate IT to align GRA...
Suggested
...Technical Project Management
Responsibilities:
This resource will act as an analyst/project manager for the Public Facing Mobile Application Governance program.
This candidate will have responsibility to ensure all stakeholders perform security due diligence...
Suggested
Full time
....
What you’ll be doing...
Supporting the VVO Investment Management team.
Establishing and facilitating cohesive work streams with... ...better if you have one or more of the following:
Strong project management skills demonstrated by a history of on-time and on-...
Suggested
Full time
Work experience placement
Work from home
Home office
Flexible hours
Project/Program Manager
Targeted Years of Experience for Project/Program Manager: 5-7 years
Responsibilities for Project/Program Manager:
•Develop project tracking tools and systems to accurately document milestone completions, project issues, project...
Suggested
...role will create and implement effective regulatory strategies to deliver on efficient and... ...US regulatory support across all global projects; meet aggressive deadlines to ensure that... ...provide regulatory support and guidance and manage day-to-day regulatory activities....
Suggested
...Summary**
Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in... ...the company as needed.
**Responsibilities**
+ Manages, directs, and drives the strategy for all Regulatory...
Suggested
...Leadership responsibility for global regulatory strategy to support the development of biomarkers... ..., testing and retesting of samples
~ Project Team Participation: Provide device-... ...RA specific inputs into CDx Risk Management plans for individual projects/indications...
Suggested
Local area
...companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late... ...evaluation and selection activities and manages multiple Companion Diagnostics Partnerships... ...Operations, Clinical Leads and Regulatory Liasions to ensure successful implementation...
Suggested
Work experience placement
Remote job
Title: Program/ Project Manager (Enterprise Privacy)
Location: One Verizon Way, Basking Ridge, NJ (NJ0533)-USA
Type: Contract (HYBRID)
Duration: Long Term
Job Description:
Targeted Years of Experience: 7-10 years
As the Program/Project...
Suggested
Contract work
Work experience placement
Shift work
...leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line management, to identify and lead global corporate initiatives... ...incl. successful delivery of regulatory projects submissions, and a working knowledge of...
Suggested
Temporary work
Work alone
...alignment and formulation of strategy for US and/or global regulatory submissions. This position ensures regulatory strategies adhere... ...(RA) team members, cross-functional team members, FDA Project Managers and/or Reviewers and may interact with ex-US Health Authorities...
Suggested
...Summary
The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier planning team... ...issues, etc. are raised on dossier planning/submission topics.
* Manages and develops internal talent ensuring a balance between...
Suggested
...rare diseases and immune disorders.
Summary
Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting... ...that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business...
Suggested
For contractors
...expedite the preparation of oncology compound regulatory submission. It will also to maintain... ...statistical programming vendor on project planning and execution to ensure high quality... ...in tandem with Biostatistics and Data Management members to ensure best vendor performance...
Suggested
For contractors
...with disabilities.
Summary
The Manager External Data Management, is accountable... ...diagnostics trials, clinical development, and regulatory submissions. The position will perform... ...stakeholders/vendors/partners.
Project Management:
Provides guidance for collection...
Suggested
Contract work
Work experience placement
...the external pharmaceutical industry and regulatory environment through participation in... ...scientists, Statistical Programming, Data Management, Medical Writing, and others to design and... ...effectively communicate results to the project team, management, and regulatory agencies...
Interim role
Local area
...the #NetworkLife.
What you’ll be doing...
As a Marketing Manager / Merchandiser on the Digital team, you will be responsible for... ...deadlines and multiple/simultaneous, highly complex, cross-functional projects/initiatives.
Experience working within a team environment...
Holiday work
Full time
Work experience placement
Remote job
Work from home
Night shift
Weekend work
...proactive safety surveillance and risk management for assigned clinical studies in partnership... ...Plan(s) (RMPs) - Contributes to regulatory authority requests or communication for... ...through inspection readiness preparation - Project Management: - Coordinates SMT/Product-level...
...and immune disorders.
Summary
Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors... ...of clinical operations and relevant regulatory requirements. This position has experience working...
Work experience placement
...not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical... ...key study documents
Knowledge of ICH/GCP and regulatory guidelines/directives
Effective project...
Local area
3 days per week
...studies, under the supervision of the Study Manager role the Study Associate Manager within... ...and other vendor performance against project goals and milestones to monitor and ensure... ...information and coordinate with DS Regulatory Operations to post trial information on...
Contract work
...business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).... ...Director, Compliance Policy, Training and Communications.
Project manage various teams to build creative training programs from...
...Director, Global Clinical Operations Study Management Group Head
About the Company... ...stakeholders such as clinical development, regulatory, and data management to ensure robust strategic... .... Extensive experience in a global project leadership role or equivalent is preferred...
...areas centered around rare diseases and immune disorders.
Summary This position is responsible for managing the team of Contract Specialists, as well as projects and processes within the Contract Management function for DSI. Working with and reporting to the Head of...
Contract work
CLINICAL TRIAL MANAGER
6+ MONTHS CONTRACT
BASKING RIDGE, NJ / TARRYTOWN, NY
HYBIRD (3 DAYS/WEEK)
NEED IMMEDIATE JOINEE, START DATE Next week Monday
VISA- NO CPT/H1B
The Temp Senior Clinical Study Lead (CSL) Clinical Experimental Sciences Operations (CES Ops)...
Permanent employment
Contract work
Temporary work
Immediate start
H1b
3 days per week
...around rare diseases and immune disorders.
**Summary**
As a Manager, Generative AI, you will be responsible for conceptualizing,... ...drug discovery and development process, clinical trials, and regulatory requirements.
**Travel**
Ability to travel up to 5% Occasional...
...are seeking is a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development. In this role, a typical day might include: Working with cross-function Manager, Oncology, Clinical, Medical Director, Regulatory Affairs, Development...
...Job Description
Job Description Customer Success Managers are the bridge between sales and customer success. You will provide support for transitioning prospects into active users, often acting as a go-between with other departments within your company, such as marketing...
Work experience placement
Summer work
...Communications function responsible for planning and managing global external and internal... ...as needed to plan and manage assigned projects
* Build, collaborate and maintain strong... ...medical affairs and marketing, legal, regulatory and congress planning
Qualifications:...
...Vendor contracts prior to study termination and contract closure. Manages all aspects of sourcing and negotiating Vendor contracts to... ...groups review. Development and management of other ad hoc special projects as they arise.
**Qualifications:** Successful candidates will...
Contract work