Technical program manager Work, Jobs in Fenstanton, Cam (with Salaries)

Director, Medical Safety Scientist
Jazz Pharmaceuticals —Cambridge
- Remote
- Management
- Doctoral degree
- Windows
- Annual leave
Delivery Practice Manager, Professional Services, UK NatSec, WWPS
AWS EMEA SARL (UK Branch) —Cambridge
- Full-time
- Computer Science
- Business development
- AWS
Senior Application Engineer - Formula 1™
MathWorks —Cambridge
- Hybrid work
- Bachelor's degree
- No degree
- Travel
Cost Management Director
AECOM —Cambridge
- Full-time
- Hybrid work
- Master's degree
- Business development
- Bachelor's degree
Business Analyst (French Speaking)
IQGeo —Cambridge
- Up to £50,000 a year
- Full-time
- Hybrid work
- English
- Organisational skills
- AI
- Annual leave
Quick apply
Software Development Manager , S3 Compute
Evi Technologies Limited —Cambridge
- Full-time
- Team management
- Recruiting
- Software development
Senior Product Manager, Cloud Operations & Infrastructure (COI)
Aveva —Cambridge
- Full-time
- Hybrid work
- DevOps
- Analysis skills
- Product management
- Annual leave
7d
Head of Quality Assurance and Regulatory Affairs
Qureight Ltd —Cambridge
- Full-time
- Hybrid work
- Project management
- Bachelor's degree
- Continuous improvement
- Annual leave
- Life insurance
Quick apply
Graduate Building Surveyor - Cambridge (Immediate start)
AECOM —Cambridge
- Full-time
- Hybrid work
- Writing skills
- Master's degree
- Bachelor's degree
4d
Principal Arboricultural Consultant
AECOM —Cambridge
- Full-time
- Hybrid work
- Business development
CNC Operator (MBs, First Shift) - 2045
Thorlabs —Ely
- Full-time
- Communication skills
- Mechanical knowledge
- Free parking
Quick apply
Principal Water Quality Scientist/ Modeller
AECOM —Cambridge
- Full-time
- Hybrid work
- Master's degree
- Mentoring
- Scripting
ECC NEC Project Manager
Mace —Peterborough
- Full-time
- Hybrid work
- Oracle
- Team management
- Construction experience
Senior/Principal Hydrogeologist
AECOM —Cambridge
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- Mentoring
Simulator Operator-Mildenhall, UK
Sawdey Solution Services —Mildenhall
- From £85,000 a year
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Outlook
Quick apply
Area Sales Manager
Bourns —Bedford
- Business development
4d
Team Lead - Software Engineering
Secondmind —Cambridge
- Full-time
- Hybrid work
- Team management
- Mentoring
- Leadership
- Annual leave
- Employee assistance programme
Quick apply
Technical Director, Capture Management Lead - Water
AECOM —Cambridge
- Full-time
- Hybrid work
- Management
- Business development
- Travel
Staff Product Security Engineer
Entrust —Cambridge
- Full-time
- Hybrid work
- Computer Science
- Master's degree
- Bachelor's degree
10d
Account Manager
Watts Industries UK Ltd —St. Neots
- Remote
- Microsoft Word
- CRM software
- Up to 50% travel
- Work from home
Quick apply

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technical program manager jobs near fenstanton, cam

Director, Medical Safety Scientist

Jazz Pharmaceuticals -
Cambridge

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Job details

Benefits

Annual leave

Qualifications

Management
Doctoral degree
Mentoring junior staff
Windows
Master's degree
Databases
Presentation skills
Bachelor's degree
Risk management
Mentoring
Computer skills
Cross-functional collaboration
Medical terminology
Cross-functional communication

Full job description

Job Details

Req ID:

R011231

Locations:

Cambridge, Cambridgeshire, UK; London, UK; Philadelphia, PA - [Remote/Home-Based]

Category:

Research & Development

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

The Director, Medical Safety (Scientist) is a key member of the Medical Safety team, and provides leadership, line management, and/or mentorship for the junior safety scientists within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role leads, oversees and coordinates all Medical Safety activities for respective TA/ product franchise as well as Medical Safety organization as a whole. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within Medical Safety organization. In close collaboration with Medical Safety Physician, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections.

Essential Functions

Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program.
Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness
Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns.
Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation.
Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required.
Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate.
Authors or provides guidance for the production of risk management plans (RMPs).
Provides strategic input into regulatory requests / responses.
Delivers clinical safety input into clinical development program.
Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications.
Participate in and/or lead internal safety surveillance meetings as well as joint safety meetings with licensing

Partners, as needed.

Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements.
Escalates issues / concerns to senior management in a timely and appropriate manner.
Mentors and trains junior members of the Medical Safety team.

Required Knowledge, Skills, and Abilities

Minimum Requirements

At least 8 years of experience in drug safety, including at least 5 years of experience in surveillance / risk management.
Ability to independently search clinical safety and literature databases for relevant information.
Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management.
Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams.
In-depth knowledge of medical and drug terminology, as well as the clinical development process.
Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases.

Required/Preferred Education and Licenses

Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline.

#LI-Remote

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings : https://careers.jazzpharma.com/benefits.html.

Apply Now

Refine Your Search

technical program manager jobs in fenstanton, cam

Director, Medical Safety Scientist

Delivery Practice Manager, Professional Services, UK NatSec, WWPS

Senior Application Engineer - Formula 1™

Cost Management Director

Business Analyst (French Speaking)

Software Development Manager , S3 Compute

Senior Product Manager, Cloud Operations & Infrastructure (COI)

Head of Quality Assurance and Regulatory Affairs

Graduate Building Surveyor - Cambridge (Immediate start)

Principal Arboricultural Consultant

CNC Operator (MBs, First Shift) - 2045

Principal Water Quality Scientist/ Modeller

ECC NEC Project Manager

Senior/Principal Hydrogeologist

Simulator Operator-Mildenhall, UK

Area Sales Manager

Team Lead - Software Engineering

Technical Director, Capture Management Lead - Water

Staff Product Security Engineer

Account Manager

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