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Vacatures bij Pharming

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Janssen&Janssen
0
QA Officer Full-time Oss

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Quality Assurance Officer in Oss.

About the role:
The QA officer ensures that the quality system at Pharming, external partners and contractors is compliant with EU and USA GMP legislation, guidelines and/or Pharming quality expectations. He or she evaluates, analyzes and prepares pharmaceutical related documents needed for batch release and compliance to GMP.

Areas of responsibilities:

Write, implement, review and maintain SOPs, policies and other QA related documentation. in alignment with applicable GxP guidelines. Identify documents which need to be created or updated and ensure this is organized.
Act as co-trainer and expert for other Quality Assurance Officers.
Organize meetings with BME and/or Pharming departments to ensure problem resolution and conducting investigations associated with deviations, Change Controls, and CAPA’s.
Review, analyze and prepare documentation related to commercial starting material production, including batch records, specifications and certificates to ensure compliance with applicable guidelines and procedures. Identify and communicate areas for improvement.
Propose ideas for site improvements.
Preparing and supporting internal and external audits in relation to applicable guidelines (like GMP, GLP, ISO, GDP, GCP).

Required skills & qualifications in order to be successful in this role:

Decisiveness
Communicative
Responsible
Quality oriented
Teamwork
Problem analysis
Behavioral flexibility
Knowledge:

Education: BSc. Biotechnology, chemistry, biopharmaceutics or equivalent

Technical skills: Extensive knowledge of and experience with GMP regulations for EU and US. (like GMP, GLP, ISO, GDP, GCP)

Experience:

Four years of experience in (bio)pharmaceutical environment with at least one year in Quality Assurance.
Janssen&Janssen
0
QA Officer Full-time · Leiden

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Quality Assurance Officer in Leiden.

About the role:
The QA officer ensures that the quality system at Pharming, external partners and contractors is compliant with EU and USA GMP legislation, guidelines and/or Pharming quality expectations. He or she evaluates, analyzes and prepares pharmaceutical related documents needed for batch release and compliance to GMP.

Areas of responsibilities:

Write, implement, review and maintain SOPs, policies and other QA related documentation. in alignment with applicable GxP guidelines. Identify documents which need to be created or updated and ensure this is organized.
Act as co-trainer and expert for other Quality Assurance Officers.
Organize meetings with BME and/or Pharming departments to ensure problem resolution and conducting investigations associated with deviations, Change Controls, and CAPA’s.
Review, analyze and prepare documentation related to commercial starting material production, including batch records, specifications and certificates to ensure compliance with applicable guidelines and procedures. Identify and communicate areas for improvement.
Propose ideas for site improvements.
Preparing and supporting internal and external audits in relation to applicable guidelines (like GMP, GLP, ISO, GDP, GCP).

Required skills & qualifications in order to be successful in this role:

Decisiveness
Communicative
Responsible
Quality oriented
Teamwork
Problem analysis
Behavioral flexibility
Knowledge:

Education: BSc. Biotechnology, chemistry, biopharmaceutics or equivalent

Technical skills: Extensive knowledge of and experience with GMP regulations for EU and US. (like GMP, GLP, ISO, GDP, GCP)

Experience:

Four years of experience in (bio)pharmaceutical environment with at least one year in Quality Assurance.
Janssen&Janssen
0
Quality Assurance
Senior Quality Assurance Officer Full-time Leiden
Quality Specialist Full-time Leiden
QA Officer Full-time Oss
QA Officer Full-time Leiden

Production
Biotechnician Full-time Oss
Animal Care Taker Full-time Oss
Senior Biotechnician Full-time Oss
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

Finance
Financial Reporting Manager Full-time Leiden

Clinical and Medical
Clinical Trial Assistant Full-time Warren, New Jersey USA

R&D
Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden
Scientist Formulation Development Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
(Sr) Director Manufacturing, Science & Technology Full-time Leiden
Junior F&E (Facility & Equipment) Engineer Full-time Oss

PMO
Project Manager Full-time Leiden

Regulatory Affairs
Medical Writer Full-time Leiden

Recruitment
Talent Acquisition Specialist Full-time Leiden

Human Resources
HR Coordinator Full-time Warren, New Jersey USA

ICT
Servicedesk Engineer Full-time Leiden

Bijgekomen;

Afgenomen:
Financial Accountant Full-time Leiden

Aantal openstaand: 21

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 45
Vervuld: 36
Janssen&Janssen
0
Quality Assurance
Senior Quality Assurance Officer Full-time Leiden
Quality Specialist Full-time Leiden
QA Officer Full-time Oss
QA Officer Full-time Leiden

Production
Biotechnician Full-time Oss
Animal Care Taker Full-time Oss
Senior Biotechnician Full-time Oss
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

Finance
Financial Reporting Manager Full-time Leiden

Clinical and Medical
Clinical Trial Assistant Full-time Warren, New Jersey USA

R&D
Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden
Scientist Formulation Development Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
(Sr) Director Manufacturing, Science & Technology Full-time Leiden
Junior F&E (Facility & Equipment) Engineer Full-time Oss
DSP Specialist Full-time Oss

PMO
Project Manager Full-time Leiden

Regulatory Affairs
Medical Writer Full-time Leiden

Recruitment
Talent Acquisition Specialist Full-time Leiden

Human Resources
HR Coordinator Full-time Warren, New Jersey USA

ICT
Servicedesk Engineer Full-time Leiden

Bijgekomen;
DSP Specialist Full-time Oss

Afgenomen:


Aantal openstaand: 22

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 46
Vervuld: 36
Janssen&Janssen
0
DSP Specialist Full-time Oss

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a DSP Specialist

About the role:
The DSP Specialist will provide front line (technical) support for the process equipment and manufacturing process during the initial startup and in future day to day operations.

Within GMP guidelines, the DSP Specialist ensures successful manufacturing production runs, by assessing risks, validating process and equipment, implementing preventative measurements, investigating, and troubleshooting processes and process equipment.

Areas of responsibilities:

Writes and/ or revises SOP’s, batch records, WI’s and other operational related documents.
Conducts technical training and guidance to production personnel.
Involved in the execution of process qualification and validation activities
To trend key performance metrics in order to avoid and/or solve process issues (continuous process verification).
Collaborates with technical, process and operational stakeholders in order to avoid and/or solve process issues.
Issues and implements CAPA/ CCR and deviations
Represents Manufacturing operations in Change Control, CAPA end deviations meetings to gather relevant information in regard to issues and implement CAPA/ CCR and deviations
Acts as SME in internal audit/ inspections.
Leads projects within DSP. Participates and/or represents department in medium complex projects.
Required skills and qualifications in order to be successful in this role:

Collaboration
Personal Agility
Analytic Ability
Problem solving
Decisiveness

Knowledge:

Bachelor’ or Master's degree e.g. (Chemical) Engineering, Pharmacy, Biochemistry, Life Science & Technology, Biology
Good technical knowledge of cGMP Compliance
Excellent knowledge of Downstream processing (e.g. chromatography/ purification and other separation technologies) and equipment
Knowledge of electronic quality systems and ERP systems is an advantage.
Excellent verbal and (technical) writing skills both in English and Dutch
Experience:

Minimal 7 years of DSP experience
A minimum of 6 years of cGMP production experience in a Downstream Processing facility
Involvement in process validation activities
Experience with lean manufacturing principles (Green Belt certified is an advantage)
[verwijderd]
0
quote:

Janssen&Janssen schreef op 3 mei 2021 14:01:



Vervuld: 36


Ik zie dat jij beweert dat 36 vacatures vervuld zijn.
Heb je daarvan een bron? Vacatures kunnen ook geannuleerd worden namelijk.
§DDDD
0
Tuurlijk een vacature wordt voor de lol geplaatst...... om de niet wetende belegger te doen geloven dat het heel erg goed gaat met je bedrijf.... LOL.
een normale belegger
0
quote:

De Monitor - Pharming Professor schreef op 3 mei 2021 14:23:


[...]

Ik zie dat jij beweert dat 36 vacatures vervuld zijn.
Heb je daarvan een bron? Vacatures kunnen ook geannuleerd worden namelijk.


Heb jij een bron dat ze geannuleerd zijn?

lijkt me geen reden voor de annulering of dat Pharming informatie deelt erover.

Janssen&Janssen
1
Quality Assurance
Senior Quality Assurance Officer Full-time Leiden
Quality Specialist Full-time Leiden
QA Officer Full-time Oss
QA Officer Full-time Leiden

Production
Biotechnician Full-time Oss
Animal Care Taker Full-time Oss
Senior Biotechnician Full-time Oss
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven
Downstream Processing Specialist Full-time Oss

Finance
Financial Reporting Manager Full-time Leiden

Clinical and Medical
Clinical Trial Assistant Full-time Warren, New Jersey USA

R&D
Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden
Scientist Formulation Development Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
(Sr) Director Manufacturing, Science & Technology Full-time Leiden
Junior F&E (Facility & Equipment) Engineer Full-time Oss


PMO
Project Manager Full-time Leiden

Regulatory Affairs
Medical Writer Full-time Leiden

Recruitment
Talent Acquisition Specialist Full-time Leiden

Human Resources
HR Coordinator Full-time Warren, New Jersey USA

ICT
Servicedesk Engineer Full-time Leiden

Bijgekomen;
DSP Specialist Full-time Oss

Rectificatie
Pharming heeft deze zelf onder production opnieuw ingedeeld ipv Technical Operations met een nieuwe naam
Downstream Processing Specialist Full-time Oss

Afgenomen:


Aantal openstaand: 22

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 46
Vervuld: 36
Janssen&Janssen
0
Quality Assurance
Senior Quality Assurance Officer Full-time Leiden
Quality Specialist Full-time Leiden
QA Officer Full-time Oss
QA Officer Full-time Leiden

Production
Biotechnician Full-time Oss
Animal Care Taker Full-time Oss
Senior Biotechnician Full-time Oss
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

Finance
Financial Reporting Manager Full-time Leiden

Clinical and Medical
Clinical Trial Assistant Full-time Warren, New Jersey USA

R&D
Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden
Scientist Formulation Development Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
(Sr) Director Manufacturing, Science & Technology Full-time Leiden
Junior F&E (Facility & Equipment) Engineer Full-time Oss

PMO
Project Manager Full-time Leiden

Regulatory Affairs
Medical Writer Full-time Leiden
Regulatory Affairs Specialist Full -time Leiden

Recruitment
Talent Acquisition Specialist Full-time Leiden

ICT
Servicedesk Engineer Full-time Leiden
Functional Application Manager Full-time Leiden
Sr. Servicedesk Engineer Full-time Warren, New Jersey USA

Downstream Processing
Downstream Processing Specialist Full-time Oss

Bijgekomen;
Regulatory Affairs Specialist Full -time Leiden
Functional Application Manager Full-time Leiden
Sr. Servicedesk Engineer Full-time Warren, New Jersey USA

Afgenomen:
HR Coordinator Full-time Warren, New Jersey USA

Aantal openstaand: 24

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 49
Vervuld: 37
Janssen&Janssen
0
Regulatory Affairs Specialist Full-time · Leiden

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Regulatory Affairs Specialist for our HQ in Leiden.

About the role:
The Regulatory Affairs (RA) Senior Specialist, in close collaboration with the Director RA, will be responsible for the creation (writing and/or compilation) of documents and adherence to appropriate legislation and regulations pertaining to the biomedical regulatory part of the medicinal product dossier. The RA Biomedical Senior Specialist is aware of the Competent Authority expectations and can pro-actively and independently convey these expectations within the organization.

Areas of responsibilities:

Investigate and analyze requirements for regulatory procedures based on legislation and regulations and ensure appropriate documents are in place. Coordinate with the relevant Pharming departments (e.g. Pharmacovigilance, Medical, Clinical, Marketing & Sales, and Supply Chain) according to the purpose of the procedure, based on the requirements of the (regional) Competent Authorities
Dependent on content expertise, write and/or review, guide, compile, and submit documents (CTAs, PSURs, DSURs, PIP, labelling, Policy 0043/0070 documents, protocols, educational materials, artwork mock-ups, promotional materials) for different regulatory procedures
Guide, coach, teach and/or instruct other Pharming departments on how regulatory requirements can be met
Evaluate compliance of advertising and / or medical information material with (inter)national legislation
Compile, finalize and distribute internally and/or externally regulatory documents such as product information (Module 1.3.1 - 1.3.2), CPPs, etc.
Maintain overviews, archive documents, follow procedures, perform life cycle management activities (e.g. in eDMS)
Ensure that eCTD files are brought and maintained up-to-date
Collect/compose required documents, set-up meetings with relevant stakeholders, create reports/minutes of meetings
Develop regulatory strategies for procedures, take initiatives and gain support for this in the relevant Pharming departments
Participate in project teams. Provide support in biomedical fields of RA to project teams
Act as contact person for regulatory authorities and provide internal and external communication regarding registration requests
Be the contact person for (inter)national partners/sites (such as eCTD publisher, pharmacovigilance provider(s), regulatory consultants, translation agencies, artwork agency/manufacturers)
Act as the internal RA representative in project teams
Act as the RA lead in assigned project teams
Required skills and qualifications in order to be successful in this role:

Independent worker
Accuracy & attention to detail
Excellent writing skills (ability to process complex scientific/medical information)
A structured approach, able to plan and organize, and set priorities
The ability to work independently and be proactive
Collaborative and good communication skills; enjoy working in a multidisciplinary team
Results-oriented
Stress resistant, resilient, and flexible

Knowledge:

A university degree (MSc.) in a relevant discipline such as Pharmacy, Pharmacology, (Medical) Biology, (Biomedical) Pharmaceutical Science

Experience with MS-Word, MS-Outlook, MS-Excel

Knowledge of regulatory procedures and EU guidelines for the content of regulatory dossiers, product information, pharmacovigilance, and drug advertising

Good command of the Dutch and English language in word and writing


Experience:

At least 4 years of experience in Regulatory Affairs
Relevant experience with regulatory procedures and compilation and/or writing of dossier module texts
Experience with eDMS
Experience with eCTD life-cycle management
Janssen&Janssen
0
Functional Application Manager Full-time · Leiden

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Functional Application Manager.

About the role:
The functional application manager advises and supports the business on ICT application requirements and collaborates with them to ensure best fit of application and optimal use by the organization. He/she is responsible for the life cycle management of a set of allocated applications, from operational functionality to maintenance, version control and upgrades of these applications.

Areas of responsibilities:

Partners with managers on ICT requirements in order to optimize existing and new application functions
Provides guidance to managers to define their requirements and translates these needs into new and/or improved solutions

Together with external partners develop and maintain the applications assigned to you to ensure availability, reliability and continuity

Collaborate with the ICT team/IT Infrastructure Specialist to maintain company infrastructure standards

Initiates, formulates and implements new features, processes and procedures within own functional area.

Provides trainings to employees both written manuals as classroom to ensure the optimal level of knowledge of users
Manage and implement changes and new releases
Required skills and qualifications in order to be successful in this role:

Organizational Sensitivity with a strong customer focus
Planning and organizing
Excellent communication skills in English and Dutch
Problem analysis skills
Agile
Result oriented
Knowledge:

HBO ICT
SAP knowledge & experience

Database knowledge

Power B.I.

Exact online knowledge

LIMS basic knowledge

Experience:
Minimum of 4 years experience in a similar role
Janssen&Janssen
0
Sr. Servicedesk Engineer
Full-time · Warren, New Jersey USA



Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Sr. Servicedesk Engineer

About the role:
The Sr. Servicedesk Engineer provides outstanding customer support for the Pharming N.V. and the US Pharming Healthcare Inc. business by responding to employee inquiries from start to finish and resolving or escalating issues relating to hardware, software and network to ensure that the most important problems are resolved promptly. The Sr. Servicedesk Engineer will provide training and set-up for new hires, manage the maintenance inventory of equipment, and provide support for system enhancements, integrations, and technology needs.

Areas of responsibilities:

Install, upgrade, support and resolve issues related to PC’s or laptops, printers, scanners, phones. LAN and WAN, hardware and software

Project support for IT as well as the US Business (e.g. data collection/hardware installation, system upgrades, M&A)

Support new system implementations and integrations and the identification and adoption of new technologies.

Ensure all systems are managed and tracked in the asset management system.

Ensure IT Operations complies with all the IT defined policies and procedures.

Diagnose hardware, software, and operator problems and take appropriate remedial actions and document installation and configuration procedures.

Testing and evaluating new hardware or software applications as upgrades or enhancements to the production environment.

Improve customer services, helping in developing competent servicedesk and tools, procedures.

Communicate with vendors that resolve issues related to software, hardware and network.

Continually interact with ICT team and document issues and resolutions addressed in Service Desk Knowledgebase.

Handle and control issues throughout their lifecycle, beginning from first point of contact until it is resolved. During this process, keep users updated on the progress.

Provide support to disaster recovery solutions and record incidents correctly and categorize and prioritize them.

Monitor SLA and ensure there are no breaches.

Suggest ideas for improving service desk functions and service delivery

Maintain security, anti-virus solutions, configure and maintain operating systems and software applications, backup devices.

Required skills and qualifications in order to be successful in this role:

Organizational Sensitivity with a strong customer focus
Planning and organizing
Excellent communication skills
Problem analysis skills
Agile
Teamwork
Eager to learn
Knowledge:

Degree in ICT / A+ Certification or equivalent

ITIL certification preferred

OS certification preferred

CSE certification preferred

Experience:
Minimum of 4 years experience experience troubleshooting network and PC hardware and software in a mixed Windows network environment.

Office 365

Windows 10

Azure

Microsoft 365

TOPdesk
Janssen&Janssen
0
Quality Assurance
Senior Quality Assurance Officer Full-time Leiden
Quality Specialist Full-time Leiden
QA Officer Full-time Oss
QA Officer Full-time Leiden

Production
Biotechnician Full-time Oss
Animal Care Taker Full-time Oss
Senior Biotechnician Full-time Oss
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

Finance
Financial Reporting Manager Full-time Leiden

Clinical and Medical
Clinical Trial Assistant Full-time Warren, New Jersey USA

R&D
Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden
Scientist Formulation Development Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
(Sr) Director Manufacturing, Science & Technology Full-time Leiden
Junior F&E (Facility & Equipment) Engineer Full-time Oss

PMO
Project Manager Full-time Leiden

Regulatory Affairs
Medical Writer Full-time Leiden

Recruitment
Corporate Recruiter Full-time Leiden

ICT
Servicedesk Engineer Full-time Leiden
Functional Application Manager Full-time Leiden
Sr. Servicedesk Engineer Full-time Warren, New Jersey USA

Downstream Processing
Downstream Processing Specialist Full-time Oss

Bijgekomen;
Corporate Recruiter Full-time Leiden

Afgenomen:
Regulatory Affairs Specialist Full -time Leiden
Talent Acquisition Specialist Full-time Leiden

Aantal openstaand: 23

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 50
Vervuld: 39
Janssen&Janssen
0
Corporate Recruiter
Full-time · Leiden

Pharming Group N.V. develops innovative therapeutics for the treatment of genetic disorders. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is growing quickly and as a result of this growth we are currently looking for a Corporate Recruiter for the Talent Acquisition department in our Leiden office.

About the role:
As Corporate Recruiter, you will be responsible for attracting and hiring talent for Pharming vacancies, ensuring that Pharming’s mission, vision and culture is incorporated in the recruitment process. The Corporate Recruiter will take part in employer branding projects, ex-and internal recruitment activities and will act as a sparring partner for hiring managers, giving advice on all recruitment matters.

Areas of responsibilities:

Effective and timely sourcing of candidates for Pharming vacancies
Strategic use of LinkedIn and other candidate sourcing channels
Provide an excellent candidate experience that incorporates Pharming’s culture and values
Participate in Employer Branding projects
Partner with hiring managers to ensure an efficient and smooth talent acquisition process
Monitor metrics to help optimize the recruitment process
Monitoring of a large volume of vacancies and tight timelines
Coordinate and plan talent acquisition activities
Advise hiring manager in selection process

Required skills & qualifications in order to be successful in this role:
Strong communication skills
Strong in building relationships/stakeholder management
Pro-active
Positive attitude
Attention to detail
Able to prioritize
Knowledge and Experience:

3-5 years work experience in a similar position
Fluent in both Dutch and English
Experience in hiring Medior/Senior/Management level positions (BSc. - PhD level roles)
Janssen&Janssen
0
Quality Assurance
Senior Quality Assurance Officer Full-time Leiden
Quality Specialist Full-time Leiden
QA Officer Full-time Oss
QA Officer Full-time Leiden

Production
Biotechnician Full-time Oss
Animal Care Taker Full-time Oss
Senior Biotechnician Full-time Oss
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

Finance
Financial Reporting Manager Full-time Leiden

Clinical and Medical
Clinical Trial Assistant Full-time Warren, New Jersey USA

R&D
Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden
Scientist Formulation Development Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
(Sr) Director Manufacturing, Science & Technology Full-time Leiden
Junior F&E (Facility & Equipment) Engineer Full-time Oss

PMO
Project Manager Full-time Leiden

Regulatory Affairs
Medical Writer Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden

Recruitment
Corporate Recruiter Full-time Leiden

ICT
Servicedesk Engineer Full-time Leiden
Functional Application Manager Full-time Leiden
Sr. Servicedesk Engineer Full-time Warren, New Jersey USA

Downstream Processing
Downstream Processing Specialist Full-time Oss

Procurement
Director Procurement Full-time Leiden

Bijgekomen;
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Director Procurement Full-time Leiden

Afgenomen:


Aantal openstaand: 25

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 52
Vervuld: 39
Janssen&Janssen
0
Regulatory Affairs (Senior) Specialist CMC
Full-time · Leiden

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Regulatory Affairs (Senior) Specialist CMC for our HQ in Leiden.

About the role:
The Regulatory Affairs (RA) (senior) specialist Chemical Manufacturing and Control (CMC) will, review, edit, write and/or compile technical documents for regulatory submissions in order to obtain swift regulatory approvals first time right. Regulatory submissions include documents that originate from different departments and/or functional areas. Investigation of the regulatory requirements and compilation of the submissions require good cross-departmental communication skills, curiosity & eagerness, open-mindedness, confidence, and no hesitation to ask questions.

Areas of responsibilities:

Review, edit, or write CMC documents (e.g. protocols, study reports, technical documents, IMPDs, annual reports, Module 2 QOS & Module 3 sections, briefing books) and ensure these are submission-ready both from a content and document-technical perspective
Compile/collect the CMC documents needed for submission packages to Competent Authorities
Act as a contact person for regulatory authorities and provide internal and external communication regarding regulatory requests
Act as an internal RA representative in (CMC) project teams, set up meetings with relevant stakeholders, create meeting reports/minutes and guard the assigned timeframe
Act as contact person for (inter)national partners/sites
Review and provide input regarding Change Control requests
Investigate and analyze requirements for regulatory documents and procedures based on the appropriate regulatory guidance
Maintain overviews, archive documents, perform life cycle management activities (e.g. in eDMS)
Ensure that eCTD files are brought and maintained up to date

Work on/with IT-systems to track regulatory submissions in each region

Roll out and implement variation packages to ROW countries in compliance with local regulatory requirements

Perform the QC on DRAFT eCTD submission packages before submission

Required skills and qualifications in order to be successful in this role:

Independent worker
Accuracy & attention to detail
A structured approach, able to plan and organize, and set priorities
The ability to work independently and be proactive
Curious and eager to learn
Collaborative and good communication skills; enjoy working in a multidisciplinary team
Stress resistant, resilient, and flexible

Knowledge:

A university degree (MSc.) in a relevant discipline such as Pharmacy, Pharmacology, (Medical) Biology, (Biomedical) Pharmaceutical Science

Preferably knowledge of regulatory procedures and guidelines for the CMC content of regulatory dossiers

Good command of the Dutch and English language in word and writing


Experience:

At least 1-2 years of experience in Regulatory Affairs
Relevant experience with regulatory procedures and compilation and/or writing of dossier module texts
Experience with MS-Word, MS-Outlook, MS-Excel
Preferably knowledge of and experience with electronic document management systems (eDMS) and eCTD granularity & life-cycle management
Janssen&Janssen
0
Director Procurement Full-time · Leiden

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Director Procurement for our HQ in Leiden.

About the role:

The Procurement Director will support the business in the sourcing and procurement process. You will help develop and implement a best-practice procurement strategy and build the new department within Pharming.

In this role you will analyze organizational spend, determine business procurement needs, assess market conditions, set clear objectives and KPIs, define procurement policies and develop the procurement strategy. You will lead the negotiations on key business contracts.

The Procurement Director will also be the SAP Business Process Owner during the SAP implementation that is currently ongoing. In that role, you will shape the Purchase to Pay process as well as contract management and supplier management. As such you will have a pivotal role in change management for these areas across the Pharming business.

Areas of responsibilities:

Develop and implement the Procurement strategy, policy and procedures, to ensure that we specify, select and contract our procurement needs
Create willingness in the organization to actively support the procurement policies and procedures, by showing the added value to the organization
Lead negotiations on key business contracts, ensuring efficient buying in line with business needs
Analyze procurement data to support decision making, ensuring partnerships with the correct suppliers
Set procurement objectives and KPIs for business needs
Lead (is Business Process Owner) in SAP implementation and after SAP go-live on Purchase to Pay process as well as contract management and supplier management
Set priorities by analyzing spend data from multiple sources with analytics tools such as PowerBI, Microsoft Excel
Serve as the primary contact for procurement related questions, training, policy and procedure interpretation and alignment by all departments
Required skills and qualifications in order to be successful in this role:

Initiative
Networking skills
Strong focus on results
Strong negotiation skills
Analytical thinker with excellent problem analysis/solving skills
Organizational sensitivity
Knowledge:

MSc. degree with a focus on Procurement, Supply Chain Management, Operations Management, Mathematics/Engineering or MBA
Nevi-2 or comparable qualification
SAP working knowledge
Sound knowledge of sourcing/procurement strategies
Knowledge of Contractual terms including IP, data protection regulation
Strong communication and presentation skills
Fluent in English and Dutch language
Experience:

At least 6 years of Procurement experience (contracting/negotiations)
Experience in the pharmaceutical industry is preferred
Janssen&Janssen
0
Quality Assurance
Senior Quality Assurance Officer Full-time Leiden
Quality Specialist Full-time Leiden
QA Officer Full-time Oss
QA Officer Full-time Leiden

Production
Biotechnician Full-time Oss
Animal Care Taker Full-time Oss
Senior Biotechnician Full-time Oss
Animal Caretaker Full-time Eindhoven
Biotechnician Full-time Eindhoven

Finance
Financial Reporting Manager Full-time Leiden

Clinical and Medical
Clinical Trial Assistant Full-time Warren, New Jersey USA

R&D
Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden
Scientist Formulation Development Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
(Sr) Director Manufacturing, Science & Technology Full-time Leiden
Junior F&E (Facility & Equipment) Engineer Full-time Oss

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK

PMO
Project Manager Full-time Leiden

Regulatory Affairs
Medical Writer Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden

Recruitment
Corporate Recruiter Full-time Leiden

ICT
Servicedesk Engineer Full-time Leiden
Functional Application Manager Full-time Leiden
Sr. Servicedesk Engineer Full-time Warren, New Jersey USA

Downstream Processing
Downstream Processing Specialist Full-time Oss

Procurement
Director Procurement Full-time Leiden

Bijgekomen;
Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK

Afgenomen:


Aantal openstaand: 27

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 54
Vervuld: 39
Janssen&Janssen
0
Regional Medical Director DACH
Full-time · DACH

Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Regional Medical Director for the DACH region.

About the role:

The medical director is responsible for developing and executing the Medical Affairs strategy in the region. He is also in the lead of identifying, hiring and onboarding the field based medical team in his region. He needs to get involved in Digital Platforms and Real-World Evidence. The position is mainly focused on immunology with an existing marketed product and on novel therapeutic(s) for condition(s) to be marketed by Pharming.

In close cooperation with upper management, the Regional Medical Director will prepare for a new product launch with a significant focus on internal and external disease and product education as well as critical reimbursement activities support. Although this position is working at a regional level, a large portion of the role will be focused on providing input and working closely with European (and Global) internal/external counterparts.

The Medical director has a highly visible role in the organization therefore it is essential for this individual to have a strong leadership background as well as senior commercial, regulatory and market access insights.

Areas of responsibilities:

Management of the Medical Affairs team consisting of MSLs
Working closely with upper management and other regional Medical Directors to implement and execute Medical Affairs strategy and operations at a regional level
Coordinate regional interests with European (& Global) Medical Affairs and provide strategic expertise helping in driving global Medical Affairs strategies
Assure cross functional engagement and collaboration, by partnering with the commercial, regulatory, market access and clinical development teams
Build and develop the Medical Affairs team, formulating a medical affairs plan utilizing internal and external resources
Medical leader for the current and upcoming launches, responsible for all pre and post launch activities
Support creation of value dossiers and provide senior medical input in discussions with the national reimbursement organizations
Involved in the implementation of Medical Affairs study activities covering all steps: from writing protocol, advising and coordination of progress of the studies as well as ensuring publications at the end of each project.
Leading the regional expanding portfolio and life cycle management strategy responsible for integrating medical perspective into the responsible region.

Required skills and qualifications in order to be successful in this role:

Teamwork
Scientific and business acumen
Leadership
Networking (cross cultural)
Able to make an impact
Strong communication skills
Knowledge:

Registered Medical Doctor
Broad therapeutic background having worked across several different portfolio's, experience working with (ultra) rare diseases is advantageous
In depth knowledge of operations in other departments such as clinical development, commercial, regulatory and market access
Experience:

Minimum of 8 years experience in the pharmaceutical industry
Cross-cultural experience
Demonstrated ability to influence and execute cross-functionally including external vendors to improve. Compliment and support internal team/performance
Proven line management experience in a dedicated Medical Affairs function
Strong experience in supporting reimbursement in the dedicated region, experience in remainder other regions is advantageous
Proven experience of a successful launch of a rare disease product in the dedicated region (advantageous)
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