Huidige banen gerelateerd aan Medicines and Medical Devices Shortages Specialist - Amsterdam - The European Medicines Agency (EMA)

  • In-house Clinician, Global Medical Devices

    4 maanden geleden

    Amsterdam, Nederland SGS Voltijd

    **Company Description** We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. As In-house Clinician,...

  • Pharmacovigilance Officer in Veterinary Medicines

    7 maanden geleden

    Amsterdam Zuid, Nederland European Medicines Agency Voltijd

    **Job grade**: FGIV **Internal job grade**: **Type of position**: Contract agent **Selection procedure reference**: EMA/CA/10436 **Job title**: Pharmacovigilance Officer in Veterinary Medicines **Sub-family**:Safety and Risk Management **Salary: 3982.82 Euro **(including local weighting) [1]** **plus** benefits **(see calculators on the right) XX -...

  • Medical Device Reimbursement Specialist

    2 dagen geleden

    Amsterdam, Noord-Holland, Nederland Undutchables Voltijd

    Unlock a rewarding career in medical device reimbursement with our dynamic team at Undutchables!About the RoleWe are seeking a highly skilled Reimbursement Specialist to join our team. As a key member of our sales support team, you will play a vital role in ensuring timely payment and approval for medical devices.Your primary responsibilities will...

  • Medical Lead Rare Diseases

    2 weken geleden

    Amsterdam, Nederland Chiesi Farmaceutici Voltijd

    **Date**:19 Dec 2024 **Department**:EU & Int'l Local Medical Affairs **Team**:Mktg, Market Access, Bus. Excellence & Med. Affair **Job Type**:Direct Employee **Contract Type**:Permanent **Location**:Amsterdam or Brussels, NL - Chiesi is looking for a Medical Lead to join the Rare team in the Benelux affiliate. This role offers a great opportunity for...

  • Medical Device Reimbursement Specialist

    2 dagen geleden

    Amsterdam, Noord-Holland, Nederland Undutchables Voltijd

    Job OverviewWe are seeking a highly skilled Medical Device Reimbursement Specialist to join our team at Undutchables. In this role, you will play a critical part in securing approval and payment for medical devices on behalf of the company.About the RoleThis is a part-time position that requires 20 hours of work per week, from Monday to Friday, 08:00 -...

  • [the Netherlands] Pms Medical Device Manager

    4 maanden geleden

    Amsterdam, Nederland Santen Voltijd

    **Company Description** Santen **is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for...

  • Collaborating Expert in Developing and Applying

    6 maanden geleden

    Amsterdam Zuid, Nederland European Medicines Agency Voltijd

    **Organizational Unit**: Stakeholders & Communication Division Not applicable Public Engagement & Stakeholders Office **Place of work**: Flexible (occasionally on EMA premises and remote). **Proposed length**: 9-12 months(extendable if needed). **Remuneration**: Experts should be salaried by their employer or be a post-graduate student (financed by their...

  • Medical Lead Real World Evidence

    7 maanden geleden

    Amsterdam, Nederland LOGEX Group B.V. Voltijd

    **Our mission**: We turn data into better healthcare. With our insights, we make healthcare more affordable, and better, and we improve the patient’s and clinicians’ experience. **Your impact and responsibilities**: As Medical lead, you are keen to provide medical perspective and knowledge in the field of real world evidence and ‘big data’...

  • Senior Medical Device Specialist

    3 dagen geleden

    Amsterdam, Noord-Holland, Nederland Yacht Voltijd

    Medical Device Specialist OpportunityWe are seeking a highly skilled Medical Device Specialist to join our team at Philips.About the Role:You will work in a highly motivated team and be part of the FORS venture which sits within the Image Guided Therapy Business.The team operates in an open, can-do and entrepreneurial atmosphere and has a self-starting...

  • Collaborating Expert On Contribution of Rwe to The

    6 maanden geleden

    Amsterdam Zuid, Nederland European Medicines Agency Voltijd

    **Organizational Unit**: Data Analytics and Methods Task Force Real World Evidence Office **Place of work**: Flexible (occasionally on EMA premises and remote). **Proposed length**: 12 months(extendable if needed). **Remuneration**: Experts should be salaried by their employer or be a post-graduate student (financed by their educational entity or...

  • Medical Lead

    7 maanden geleden

    Amsterdam, Nederland Novartis Voltijd

    **Summary**: Medical Lead - Multiple Sclerosis and Immunology Location: Amsterdam As Medical Affairs Lead you will lead a (field) team responsible for driving the Medical Affairs strategy and tactics in line with the Global strategy and local needs of the relevant therapeutic areas for the Priority Brands/pre-launch products. You will lead a (field) team...

  • Collaborating Expert On Risk Assessment of The Use

    6 maanden geleden

    Amsterdam Zuid, Nederland European Medicines Agency Voltijd

    **Organizational Unit**: Data Analytics and Methods Task Force Not applicable TDA Office **Place of work**: Flexible (occasionally on EMA premises and remote). **Proposed length**: 6 months(extendable if needed). **Remuneration**: Experts should be salaried by their employer or be a post-graduate student (financed by their educational entity or...

  • Part-Time (20hrs) Reimbursement Specialist | German | Medical Sector

    3 weken geleden

    Amsterdam, Nederland Undutchables Voltijd

    THIS POSITION A PART TIME , 20 HOURS/WEEK - Monday to Friday from 08.00 - 12.00.As a Reimbursement Specialist, your main job is to help the company get approval and payment for medical devices. THIS POSITION A PART TIME , 20 HOURS/WEEK - Monday to Friday from 08.00 - 12.00.As a Reimbursement Specialist, your main job is to help the company get approval and...

  • Medical Publications Manager

    6 maanden geleden

    Amsterdam, Nederland Omnicom Health Group Voltijd

    Overview: **About us** Excerpta Medica is a fast-growing medical communications agency; we are part of the Adelphi Group and seamlessly connected to the full Adelphi offerings of real-world evidence, market access, and research. We are also part of the Omnicom Health Group, the largest healthcare marketing and communications network in the world. At...

  • Director, International Scientific Communications

    2 weken geleden

    Amsterdam, Nederland Rhythm Pharmaceuticals Voltijd

    **Company Overview** Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We...

  • Principal Medical Writer II

    1 week geleden

    Amsterdam, Nederland CSL Seqirus Voltijd

    The Principal Medical Writer is a key member of cross-functional clinical project teams. The incumbent will be responsible for planning, preparing, managing and coordinating medical writing projects for Clinical Development within R&D. They will mitigate risk associated with medical writing and disclosure processes by participating in the development and...

  • Principal Medical Writer II

    4 weken geleden

    Amsterdam, Nederland CSL Seqirus Voltijd

    The Principal Medical Writer is a key member of cross-functional clinical project teams. The incumbent will be responsible for planning, preparing, managing and coordinating medical writing projects for Clinical Development within R&D. They will mitigate risk associated with medical writing and disclosure processes by participating in the development and...

  • Principal Medical Writer II

    1 maand geleden

    Amsterdam, Nederland CSL Seqirus Voltijd

    The Principal Medical Writer is a key member of cross-functional clinical project teams. The incumbent will be responsible for planning, preparing, managing and coordinating medical writing projects for Clinical Development within R&D. They will mitigate risk associated with medical writing and disclosure processes by participating in the development and...

  • IT Program Manager/ Customer Portfolio Lead

    7 maanden geleden

    Amsterdam Zuid, Nederland European Medicines Agency Voltijd

    **Job grade**: AD06 **Interagency/Internal job grade**: AD06 and above **Type of position**: Temporary agent **Selection procedure reference**: EMA/AD/10461 **Job title**: IT Program Manager/ Customer Portfolio Lead **Sub-family**:Customer Portfolio Relationship Management **Monthly Salary: 6,661.12 Euro **(including local weighting) [1]** **plus**...

  • Phd Medical Ai and Medication Recommendation in The

    7 maanden geleden

    Amsterdam-Zuidoost, Nederland Amsterdam UMC Voltijd

    **About the project**: Patients admitted to the ICU are often treated with multiple high-risk medications. Yet, our knowledge of safety and effectiveness of pharmacotherapy in ICU patients is limited. Consequently, over - and underprescribing of indicated medications, and inappropriate choice of medications, frequently occur in ICU patients. Medication...

Medicines and Medical Devices Shortages Specialist

4 maanden geleden

Amsterdam, Nederland The European Medicines Agency (EMA) Voltijd

Medicines and Medical Devices Shortages Specialist

Type of position: Temporary agent Job Type: Extended until 12 September 2024 at 23:59 CET

Job grade : AD06 

Internal job grade and Interagency: AD06 and above

Type of position : Temporary agent 

Selection procedure reference : EMA/AD/10618 

Job title : Medicines and Medical Devices Shortages Specialist 

Talent Pool: AD06 Science & Regulation

Deadline for applications : Extended until 12 September 2024 at 23:59 CET 

Salary: 6,418.36 Euro (including local weighting) plus benefits (see calculators on the right) (based on a fulltime contract (40hrs/week))

XX

About this position:

We are looking for a Medicines and Medical Devices Shortages Specialist to provide scientific secretarial support to the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), management and support of the Single point of Contact Working Party (SPOC WP ) and Industry Single point of Contact (i-SPOC) systems for medicines, and case management of shortages of CAPs and critical shortages. 

Job holder's role and responsibilities: 

Management of assigned shortage cases, ensuring timely and relevant communication between all stakeholders, with a view to mitigate and manage shortages and ensure availability of product for patients; Discussion of cases escalated to the Medicine Shortages SPOC WP; Identification of shortages/events that could lead to a major event for discussion at the MSSG.

Here is the link to the Role Description of Medicines and Medical Devices Shortages Specialist outlining the generic duties and responsibilities:

Apply if you meet these eligibility criteria:

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:
General conditions:
1. enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
2. have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
3. have fulfilled any obligations imposed by applicable laws concerning military service.

Specific conditions:
1. possess a university degree (minimum of three years) in scientific (pharmacy, chemistry, biology or an equivalent) or technical (e.g. applied science) disciplines
and at least 3 years of professional experience after obtaining the relevant degree, that must have been obtained by the closing date.


General Condition 1 and Specific Conditions will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure. 
Only candidates eligible will be assessed by the Selection Committee in accordance with the Assessment Criteria below.

You will also need to have:

Experience:

At least 3 years of experience  in the management of shortages, supply chain and manufacturing of medicinal products for human use and/or medical devices, obtained through previous work in academia, industry, notified body, EU competent authority. This experience can overlap or be in addition to the 3 years of professional experience required for Eligibility and listed under Specific Conditions 1. Experience in interaction with stakeholders such as patients, healthcare professionals, academia, pharmaceutical and/or medical device industry.

Competencies you will need to have:

Role competencies

Shortage management & availability - Intermediate

Sub-family competencies

Regulatory frameworks & strategy - Intermediate Applied knowledge - Intermediate

Grade competencies

Adaptability and agility - Intermediate Analysing and problem solving - Intermediate Prioritising and organising - Intermediate

Core competencies

Ethics and Integrity - Intermediate Team collaboration - Intermediate Customer centricity - Intermediate Results orientation - Intermediate Communication Intermediate Cross-cultural sensitivity - Intermediate Continuous learning and self-development - Intermediate

The assessment of competencies forms an important part of this selection process. EMA therefore advises you to refer to its for more information on the definitions of these competencies and their associated levels.

These are considered Nice to have:

Experience

In working in a multicultural environment; Project management experience in leading, coordination, planning, implementation, evaluation and timely delivery of projects.

Skills & Knowledge 

A clear understanding of the role of EMA within the legislative framework for the regulation of medicinal products and medical devices.

Selection procedure timelines

Deadline for applications

extended until 12 September 2024 at 23:59 CET 

Preliminary Assessments

Foreseen: 08 October 2024 

Final assessments

Foreseen: between 21 and 25 October 2024 

Decision expected

First week of November 2024

Selection process

Only eligible candidates (see eligibility criteria) will be assessed by the selection committee.

Suitability and qualifications of eligible candidates will be assessed against the assessment criteria and competences in different steps of the selection procedure.

Note: Candidates who fail any assessment linked to any Need to Have requirement, Sub-family competencies, Grade specific competencies, Role competencies and Core Competencies at any stage of the process are disqualified, despite getting points on other criteria.

X

Shortlisting

In order to allow the selection committee to carry out an objective assessment of all candidates in a structured way, as part of their application, all candidates must answer the pre-defined set of questions based on Need to have criteria, Sub-family competencies and Role competencies. 

The Selection Committee will therefore assess eligible candidates using the information provided in the responses to those questions and in their application. When answering a question, you should include all relevant information , even if it is already mentioned in other sections of your application form.

To carry out this assessment, each of your responses will be awarded points (0 to 10). The points are added up to identify those candidates whose profiles best match the duties to be performed as advertised in the vacancy notice.

X

Assessments

Next steps of selection may include a preliminary assessment. Most assessments will be conducted remotely (i.e. Webex/Teams, remote test, etc.). All assessments are based on the assessment criteria listed in this vacancy notice.

Shortlisted candidates will participate in personality assessments (e.g. SHL occupational personality questionnaire OPQ32) to assess their Core Competencies (pass score is 26 out of 100 points and above).

Additional assessments, such as cognitive (e.g. deductive reasoning) assessments might also be foreseen as part of the selection process. Furthermore, motivation and overall fit for the job and knowledge of EU relevant to role may be assessed.

X

Reserve list and/or job offers

When a vacancy becomes available, candidates on the reserve list may be contacted for an additional interview.

More information about selection and recruitment (including administrative complaint procedure) at the EMA is available at our .

X

Conditions of employment

In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates.

The successful candidate will be required to relocate to the Netherlands to pick up duties.

______________________________________________________________________________________________________