Pharming « Terug naar discussie overzicht

Vacatures bij Pharming

679 Posts, Pagina: « 1 2 3 4 5 6 ... 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 » | Laatste
Janssen&Janssen
0
Regional Medical Director UK
Full-time · UK

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 UK and Nordics 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)
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;
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands

Afgenomen:


Aantal openstaand: 30

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 57
Vervuld: 39
Janssen&Janssen
0
Regional Medical Director FR/BENELUX
Full-time · The Netherlands



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 France/BENELUX 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)


Janssen&Janssen
0
Regional Medical Director Iberia/Italy
Full-time · Spain



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 Iberia/Italy 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)
Janssen&Janssen
0
Regional Director Medical Information and Communication
Full-time · The Netherlands



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 Director Medical Information & Communication.

About the role:

The Director Medical Information and Communication develops the best-in-class medical information service, in cooperation with pharmacovigilance and commercial, and communication strategy for a transitioning biotech company in alignment with the brand plan, corporate and US communication needs. The director contributes to (pre)launch activities, e.g., like organizing conferences (pre-launch Leniolisib), establishes a medical information system and operationalizes the medical communication strategy, while building out the respective department as needed for current and additional products.

Areas of responsibilities:

Develops and delivers the best-in class medical information service, including related scientific writing, compilation and archiving of response materials whilst collaborating with existing medical affairs and pharmacovigilance team members to ensure compliance with regulatory guidelines

Leads and manages the development and appropriate distribution of educational materials including internal and external medical training materials in collaboration with pharmacovigilance, regulatory and commercial stakeholders

Leads and manages the development and appropriate distribution of educational materials including internal and external medical training materials in collaboration with pharmacovigilance, regulatory and commercial stakeholders

Builds out the department for medical information and communication to ensure highest quality standards, while minimizing outsourcing costs as the product portfolio increases

Works with client provided complex medical and technical information, able to present this clearly and proficiently in an audience dependent manner in order to optimize the product portfolio offering

Leads the publication access and database management across EU&ROW in compliance with copyright requirements and other legal requirements as needed in order to consolidate the process across the company and ensure copyright compliance

Leads the (pre-launch) conference management and related medical information needs post launch for current and new products

Develops the medical communication strategy for EU & ROW in alignment with the brand plan corporate and US communication needs and manages the tactics in order to position the product(s) in a highly competitive environment

Leads and delivers the product related training for both internal and external stakeholders to ensure scientific data and medical concepts are understood and consistent with the agreed strategic direction

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

Initiative
Scientific and business acumen
Stakeholder and people management
Cultural awareness
Strong communication skills
Knowledge:

Degree in medicine, PhD/PharmD (minimum qualification is a degree in Pharmacy or biological sciences)
Ability to critically review scientific and medical information and develop balanced impactful standard response letters
Excellent knowledge of the English language

Experience:

Minimum of 3 years experience within a Medical Information or Medical Communications role. Additional (line) management experience in other medical or non-medical functions within the pharmaceutical or biotech industry is strongly preferred.
Highly experienced in Medical Information services responses across a number of therapeutics/therapy areas and related pharmacovigilance experience
Prove experience in medical communication strategies and tactics
Highly experienced in stakeholder management, building relationships and influencing both internal and external
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
Senior 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;
Senior Corporate Recruiter Full-time Leiden

Afgenomen:


Aantal openstaand: 31

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 58
Vervuld: 39
Janssen&Janssen
0
Senior 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 Senior Corporate Recruiter for the Talent Acquisition department in our Leiden office.

About the role:
As Senior Corporate Recruiter, you will liaise with in and external stakeholders for all Pharming's hiring matters. This includes attracting and hiring talent for Pharming vacancies, ensuring that Pharming’s mission, vision and culture is incorporated in the recruitment process and partnering with the business for short and long term hiring needs. The Senior 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:

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

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:

5+ years work experience in a corporate recruiter position
BSc. or higher in a relevant discipline (experience/affinity with Life Sciences is a major plus!)
Fluent in both Dutch and English
Experience in senior level stakeholder management
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

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands
MSL Diagnostic Specialist Full-time The Netherlands

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
Senior 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;
MSL Diagnostic Specialist Full-time The Netherlands

Afgenomen:


Aantal openstaand: 32

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 59
Vervuld: 39
Janssen&Janssen
0
MSL Diagnostic Specialist Full-time · The Netherlands

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 MSL Diagnostic Specialist.

About the role:

The Medical Science Liaison establishes and maintains relationships with appropriate target physicians, researchers, and clinicians and key opinion leaders (KOLs) to ensure that products are used effectively. The Medical Science Liaison serves as scientific resource and expert, advises on current and upcoming advances in treatments, and provides input about relevant scientific and clinical data. He/she coordinates cross functional LCM strategies and executes medical affairs programs of therapeutic areas at local country (cluster) level.

Areas of responsibilities:

Develops and maintain long term relationships with local KOLs with a view to supporting IIT/medical project development in therapeutic areas of interest in line with local MA plan

Provide in-depth medical scientific training and support to commercial (marketing and/or non-science) teams in the appropriate territories

Utilizes field knowledge and insight to develop and support strategic and tactical objective of therapeutic area. Provides input to EU/US brand strategy

Provide KOL insights and observations to the medical affairs team on a timely basis

Help to ensure that KOL speakers have access to appropriate scientific data

Participate in coordinating and conducting peer-to-peer interactions and medical presentations

Remain up-to-date in appropriate therapeutic areas of focus to Pharming

Provide medical support to Pharming’s clinical research programs and registries

Provide overall medical / scientific support through the dissemination of on-label educational, scientific, and clinical information on diseases and its treatment, for training purposes only

Develop relationships with local thought leaders (physicians, pharmacists and nurses) whose opinions and treatment regimens influence the practice of their colleagues

Identify unsolicited requests for investigator-initiated research

Disseminate to physicians, nurses and other healthcare professionals state-of-the-art on-label research and medical concepts related to the treatment and management of diseases of interest to the company

Represent Medical Affairs at continuing educational events / programs, medical meetings and scientific conventions.

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

Networking
Teamwork
Persuasiveness
Cultural awareness and sensitivity
Strong communication skills
Self-starter/independent
Knowledge:

Professional qualification; MD, PhD, PharmD
Strong medical and scientific knowledge with experience of Immunology and/or specialty therapeutic areas advantageous

Strong command of English language (verbal, written) and a second European language would be an advantageous (German, French, Spanish, Portuguese, Italian)

Understanding of the ABPI Code of Practice/EFPIA guidelines (training will be provided) and in-country local code insight advantageous

Experience:

3+ years of experience as an MSL
5+ years of work experience, preferably in the biotech/pharma industry
Proven success working with local EU operating company models, processes, cultures, languages and functions
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
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

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
Senior 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 Writer Medical Affairs Full-time The Netherlands

Afgenomen:


Aantal openstaand: 33

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 60
Vervuld: 39
Janssen&Janssen
0
Medical Writer Medical Affairs Full-time The Netherlands

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 Medical Writer Medical Affairs.

About the role:

The medical writer will conduct research into scientific studies and publications across the various product franchises and creates medical & scientific presentations/publications, for internal and external audiences, such as conferences, medical journals, as well as market access dossiers, based on scientific knowledge and applicable publication guidelines and legislation.

Areas of responsibilities:

Compile, write, and edit medical writing deliverables for presentations / publications for a broader audience, including scientific liaisons, healthcare professionals, and pharmaceutical representatives in line with the medical affairs and brand plan

Write and review market access dossiers, such as reimbursement dossiers and health technology applications in line with the brand & commercial development plan

Stay up to date with the scientific literature relevant for the Pharming product portfolio in order to position the product features for the optimized use in patients in any medical affairs communication

Write state of the art publications for journals with highest impact factors (e.g., NEJM, Lancet, etc.) based on technical documents, such as clinical study reports

Review and edit promotional material for internal and external audiences in order to ensure consistency across the medical affairs publications and communication tools

Stay up to date for medical writing guidance and policies, whether international or national standards, as relevant for the publication.

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

Planning/organizing
Teamwork/cross-functional
Scientific acumen
Initiative
Strong communication/writing skills
Self-starter/independent
Knowledge:

Master’s degree or PhD (strongly preferred) in (Bio)pharmaceutical Sciences, Biomedical Sciences, Biotechnology, Medical Biology or Medicine
Ability to understand/process complicated scientific and/or medical information and write presentations, publications, dossiers in a clear and concise manner

Thorough understanding of publication guidelines

EFPIA and ABPI experience

Excellent writing skills in English

Experience:

3+ years of relevant medical writing experience
Experience in writing/compiling medical presentations/publications
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
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

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
Senior Corporate Recruiter Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

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;
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

Afgenomen:


Aantal openstaand: 34

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 61
Vervuld: 39
Janssen&Janssen
0
Associate Director Regulatory Affairs 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 Associate Director Regulatory Affairs (Labeling/Ad Promo).

About the role:
The Associate Director Regulatory Affairs (Labeling/Ad Promo)will be responsible for developing, implementing, and advising on labeling strategies for Pharming products in development as well as marketed products. This individual will manage regulatory labeling through all phases of development, and post-approval. The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met. The Associate Director, Labeling/Ad Promo Regulatory Affairs will also be responsible for overseeing the regulatory assessment and research on regulatory precedence, to evaluate advertising/promotional activities and materials.

Areas of responsibilities:

Provides high level strategic and operational regulatory direction on projects including, but not limited to general regulatory labeling strategies, requirements, and associated risk assessments

Demonstrated thorough understanding of product labeling regulatory requirements in the pharmaceutical industry and healthcare environment, including policy trends

Extensive regulatory experience leading and managing the development and maintenance of product labeling, and associated review processes externally as well as internally by managing the preparation and revision of regional labeling

Ensure labeling content is accurate and in accordance with Health Authority requirements

Provide regulatory leadership and guidance to the commercial and marketing team(s) during the development, review, and approval of product labeling and advertising materials

Working with the regulatory operations team, prepares and submits appropriate ad/promo documentation to Health Authorities aligned with regulations

Actively participates in the resolution of key regulatory issues from the labeling and ad promo perspective

Works directly with the marketing teams from concept through review and approval, up to and including submissions

Maintains awareness of global regulatory environment and assess impact of changes on business and product labeling activities

Responsible for assisting with the development and implementation of regulatory processes from the labeling/ad promo perspective



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

Influencing
Negotiation skills
Teamwork
Strong communicator/ability to present to Sr. Leaders & Health Authorities
Cross-functional Collaboration
Stakeholder management

Knowledge:

Bachelor’s degree in a life sciences or technical field from an accredited university; advanced degree preferred. RAC certification preferred

In depth knowledge of U.S. FDA requirements for pharmaceuticals and biologics


Experience:

5+ years related experience in Regulatory Affairs

5+ years of experience involving the direct implementation of promotional labeling in the biotech/pharmaceutical industry

3+ years of experience with advertising regulations; this must include experience providing regulatory input and evaluation as part of a promotional review committee.
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
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
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

PMO
Project Manager Full-time Leiden

Regulatory Affairs
Medical Writer Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

Recruitment
Corporate Recruiter Full-time Leiden
Senior 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;


Afgenomen:
(Sr) Director Manufacturing, Science & Technology Full-time Leiden

Aantal openstaand: 33

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 61
Vervuld: 40
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
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

PMO
Project Manager Full-time Leiden

Regulatory Affairs
Medical Writer Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

Recruitment
Corporate Recruiter Full-time Leiden
Senior 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;
External Manufacturing Manager Full-time Leiden

Afgenomen:

Aantal openstaand: 34

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 62
Vervuld: 40
Janssen&Janssen
0
External Manufacturing 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 External Manufacturing Manager

About the role:
The External Manufacturing Manager ensures that our manufacturing processes are fit for purpose and that Drug Substance (DS) and Drug Product (DP) are manufactured through our CMO (Contract Manufacturing Organization) partners for which (s)he owns the account. Aiming at delivering quality products through a reliable supply chain, the Manager ensures adequate process transfer from R&D, validation, continuous process performance to increase efficiency and robustness.

Areas of responsibilities:

Main point of contact for Manufacturing processes at multiple CMO’s
To implement and validate Manufacturing related changes at CMO’s in order to develop scientifically sound processes and to keep them aligned with our own internal manufacturing process (if applicable) and ensure alignment between our DS (drug substance) and DP (drug product) processes
To perform and report risk assessments of Manufacturing related topics at CMOs in order to minimize risks and balance efforts
To ensure progress of assigned Manufacturing related projects (incl deviations, CAPAs and commitments to authorities) at CMOs in order to meet the timelines
To be the spokesperson for Pharming wrt Manufacturing in case of regulatory audits at the CMO’s
To perform Manufacturing related activities at CMOs according to the Pharming quality system in order to stay in compliance with cGMP guidelines
To set up study plans, interpret/trend data and report results in final reports in order to have scientifically sound data to support the filing
Represent MS&T-Manufacturing in multidisciplinary projects
Keep up to date with new technologies and developments relevant to biotech/pharma industry
Required skills and qualifications in order to be successful in this role:

Problem analysis: connects different aspects of information to gain insight, questions (perceived) certainties to come up with solutions with the team
Collaboration: actively contributes to a common result or problem solving, also when this exceeds the boundaries of the MST team
Decisiveness: makes timely decisions, even if all information is not available, considering the consequences (risk-based approach)
Creativity: searches for innovation and comes up with original ideas
Persuasiveness: conveys his/her point in an impactful manner and achieves a positive result with a difficult proposition. States the common interest
Oral and written communication: separating main issues from secondary issues and sharing information in a logical order
Knowledge:

Master's degree or PhD e.g. (Chemical) Engineering, Pharmacy, Biochemistry, Life Science & Technology, Biology
Excellent understanding of manufacturing processes (biologics, small molecules), documentation requirements, systems and equipment
Excellent understanding of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (EMA, FDA, ICH)
Excellent verbal and technical writing skills in English (Dutch and French is an advantage)
Experience:

Minimal 10 years of working experience of which 7 years in the Pharma industry
Janssen&Janssen
0
Quality Assurance
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
Scientist Formulation Development Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

PMO
Project Manager Full-time Leiden

Regulatory Affairs
Medical Writer Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

Recruitment
Corporate Recruiter Full-time Leiden
Senior 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;

Afgenomen:
Senior Quality Assurance Officer Full-time Leiden
Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden

Aantal openstaand: 32

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 62
Vervuld: 42
Janssen&Janssen
1
Quality Assurance
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
Scientist Formulation Development Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

PMO
Project Manager Full-time Leiden

Regulatory Affairs
Medical Writer Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

Recruitment
Corporate Recruiter Full-time Leiden
Senior 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;

Afgenomen:
Director Procurement Full-time Leiden

Aantal openstaand: 31

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 62
Vervuld: 43
Janssen&Janssen
0
Quality Assurance
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
Scientist Formulation Development Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

Regulatory Affairs
Medical Writer Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

Recruitment
Corporate Recruiter Full-time Leiden
Senior 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;

Afgenomen:
PMO
Project Manager Full-time Leiden

Aantal openstaand: 30

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 62
Vervuld: 44
Janssen&Janssen
0
Quality Assurance
Quality Specialist 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

R&D
Scientist Formulation Development Full-time Leiden

Technical Operations & QC
CQV Engineer Full-time Oss
Junior F&E (Facility & Equipment) Engineer Full-time Oss
External Manufacturing Manager Full-time Leiden

Medical Affairs
Regional Medical Director DACH Full-time DACH
Regional Medical Director UK Full-time UK
Regional Medical Director FR/BENELUX Full-time The Netherlands
Regional Medical Director Iberia/Italy Full-time Spain
Regional Director Medical Information and Communication Full-time The Netherlands
MSL Diagnostic Specialist Full-time The Netherlands
Medical Writer Medical Affairs Full-time The Netherlands

Regulatory Affairs
Medical Writer Full-time Leiden
Regulatory Affairs (Senior) Specialist CMC Full-time Leiden
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA

Recruitment
Corporate Recruiter Full-time Leiden
Senior 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

Investor Relations
Investor Relations Assistant Full-time Leiden

Bijgekomen;
Investor Relations Assistant Full-time Leiden

Afgenomen:
QA Officer Full-time Oss
QA Officer Full-time Leiden
Clinical Trial Assistant Full-time Warren, New Jersey USA

Aantal openstaand: 28

Totaal vacatures toe of afname vanaf 29 sept 2020
Bijgekomen: 63
Vervuld: 47
679 Posts, Pagina: « 1 2 3 4 5 6 ... 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 » | Laatste
Aantal posts per pagina:  20 50 100 | Omhoog ↑

Meedoen aan de discussie?

Word nu gratis lid of log in met uw e-mailadres en wachtwoord.

Direct naar Forum

Detail

Vertraagd 23 mei 2022 17:35
Koers 0,777
Verschil +0,008 (+0,97%)
Hoog 0,785
Laag 0,768
Volume 1.963.884
Volume gemiddeld 3.897.779
Volume gisteren 2.144.396

EU stocks, real time, by Cboe Europe Ltd.; Other, Euronext & US stocks by NYSE & Cboe BZX Exchange, 15 min. delayed
#/^ Index indications calculated real time, zie disclaimer, streaming powered by: Infront