Find National specification manager Jobs in Dublin, D

Senior Manager, Aggregate Reporting Management
Regeneron —Dublin, County Dublin
- €86,800–€141,200 a year
- Writing skills
- Analysis skills
- Project management
- Annual leave
11d
Healthcare Records Manager
Beaumont Hospital —Dublin, County Dublin
- €58,477–€66,677 a year
- Overtime
- Management
- English
- Leaving certificate
- Annual leave
10d
Project Contract Manager
ALSTOM —Dublin, County Dublin
- €80,000–€100,000 a year
- Management
- Engineering
- Project management
- Annual leave
National Coach Developer
Football Association of Ireland (FAI) —Dublin, County Dublin
- Full-time
- Hybrid work
- Administrative experience
- Project management
- No degree
- Free parking
- Employee assistance program
Business Administration Manager
Teagasc —Ashtown, County Dublin
- €53,740–€75,788 a year
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Dublin Clinical Services Manager
Merchants Quay Ireland —Dublin, County Dublin
- €60,215–€71,386 a year
- Full-time
- Management
- Clinic
- Analysis skills
- Annual leave
- Employee assistance program
Quick apply
2d
Macra Make the Moove Project Manager
Macra na Feirme —Dublin, County Dublin
- €50,000–€55,000 a year
- Part-time
- Hybrid work
- Project management
- Communication skills
- Work from home
- Employee assistance program
Quick apply
8d
Applications Development Senior Manager
Citi —Dublin, County Dublin
- €93,280 a year
- Full-time
- Hybrid work
- Oracle
- DevOps
- System design
Product Deployment Engineer Manager, gTech
Google —Dublin, County Dublin
- €182,000–€197,000 a year
- Full-time
- Java
- Master's degree
- SQL
10d
Senior Operations Manager
Jabil Circuit —Dublin, County Dublin
- Full-time
- English
- Organisational skills
- Agile
9d
Lead Planner - ETCS Onboard Programme
ALSTOM —Dublin, County Dublin
- €70,000 a year
- Weekend availability
- Microsoft Excel
- Analysis skills
- In-person
- Annual leave
Territory manager Diageo THT
CPM Ireland —Dublin, County Dublin
- €30,000–€35,000 a year
- Full-time
- Sales
- Retail management
- Fuel card
- Employee assistance program
Quick apply
12d
Lead Project Manager
ALSTOM —Dublin, County Dublin
- €85,000 a year
- Every weekend
- Sales
- Project management
- In-person
- Annual leave
National Coach Developer
Football Association of Ireland —DUBLIN 15, County Dublin
- Hybrid work
- Administrative experience
- Project management
- No degree
- Free parking
- Employee assistance program
Quick apply
11d
Regional Infrastructure Director
Microsoft —Dublin, County Dublin
- €113,600–€213,700 a year
- Full-time
- Engineering
- Project management
- Bachelor's degree
Finance Manager
Acquired Brain Injury Ireland —Dublin, County Dublin
- €57,856–€75,210 a year
- Full-time
- Remote
- Microsoft Excel
- Microsoft Office
- Presentation skills
- Employee assistance program
10d
Regional Programme Coordinator (Dublin South Leinster Region)
Irish College of GPs —Dublin, County Dublin
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Project management
- Annual leave
- Employee assistance program
Quick apply
Assistant General Manager
Hines —Dublin, County Dublin
- On call
- Hospitality
- Customer service
- Microsoft Office
Procurement Manager
Turner & Townsend —Dublin, County Dublin
- Full-time
- Master's degree
- Contracts
- Leadership
- Annual leave
Quick apply
2d
Packaging Manager/Expert for Labels, Flexibles and Bags (d/f/m)
Henkel —Dublin, County Dublin
- Full-time
- Engineering
- English
- Master's degree
- Work from home
Quick apply

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Senior Manager, Aggregate Reporting Management

Regeneron -
Dublin, County Dublin

Apply Now

Job details

€86,800–€141,200 a year
11 days ago

Benefits

Annual leave

Qualifications

Writing skills
Analysis skills
Project management
Bachelor's degree
Communication skills

Full job description

Regeneron's Patient Safety organization is seeking a Senior Manager, Aggregate Reporting Management to join our team!

In this role, a typical day might include:

This position in the Global Patient Safety (GPS) Operations is responsible for management of aggregate safety reporting activities across all phases of the product lifecycle. This role supports the consistent, compliant, and scientifically robust preparation, distribution and submission of periodic and ad-hoc safety reports to health authorities, collaborators and contract research organizations worldwide.

This role might be for you if you can/have:

Drives preparation, development and maintenance of Aggregate Reporting (i.e., PSURs/PBRER, PAER, DSURs, Local Periodic Reports, SUSARs) Deliverables
Leads Aggregate Report planning, production and distribution activities across GPS and other functions across US, EU, Japan and other ICH regions, as well as non-ICH regions
Provides expertise and guidance to authors and contributors of aggregate reports
Maintains compliance metrics and contributes to implementation of Quality Events and Corrective Action and Preventive Action (CAPA) for non-compliance
Implements effective structure, procedures and tools to ensure aggregate reports and other functional deliverables are completed timely and with high quality
Develops and oversees functional specifications of data requirements for aggregate deliverables from the safety and clinical databases
Collaborates with Global Patient Safety (GPS) and with other functional areas (Epidemiology, Clinical Development, Regulatory Affairs, Statistics, etc.) contributing to aggregate safety reports
Acts as subject matter expert during audits and inspection.
Provides oversight, and training as needed of CRO respective activities in support of high quality and timely aggregate reports
Acts as a functional vendor management overseeing and driving high quality outputs from our vendors
Develops and maintains aggregate report procedural package (SOPs, Work Instructions), reports’ templates, KPIs
Drives process improvement through automation and other tech initiatives.

To be considered for this opportunity, you must have the following:

Bachelor’s degree required (advanced degree or HCP‑focused background preferred) and 5+ years of Pharmacovigilance experience, with a demonstrated focus on Aggregate Safety Reporting.
Project management experience strongly preferred, PMP preferred
Experience with health authority inspections (PV and GCP)
Medical writing experience with regulatory documentation
Strong project management skills
Excellent strategic decision-making and analytical skills
Strong communication and writing skills
Strong understanding of Scientific content
Proven experience with technology implementations allowing for streamlined process execution.

#GDPSJobs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

€86,800.00 - €141,200.00

Apply Now

Refine Your Search

national specification manager jobs in dublin, d

Senior Manager, Aggregate Reporting Management

Healthcare Records Manager

Project Contract Manager

National Coach Developer

Business Administration Manager

Dublin Clinical Services Manager

Macra Make the Moove Project Manager

Applications Development Senior Manager

Product Deployment Engineer Manager, gTech

Senior Operations Manager

Lead Planner - ETCS Onboard Programme

Territory manager Diageo THT

Lead Project Manager

National Coach Developer

Regional Infrastructure Director

Finance Manager

Regional Programme Coordinator (Dublin South Leinster Region)

Assistant General Manager

Procurement Manager

Packaging Manager/Expert for Labels, Flexibles and Bags (d/f/m)

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