Sciences de la vie

Coordinateur Assurance Qualité Système

Notre client, une entreprise internationale spécialisée dans les dispositifs médicaux et en pleine croissance depuis plusieurs années,  recherche actuellement un Ingénieur Assurance Qualité Système afin d’agrandir son équipe qualité dans le cadre d’une forte croissance.

VOS MISSIONS:

– Être garant des diverses projets dans le département Assurance Qualité

– Travailler les processus CAPA, Analyses de Risques en lien avec l’ensemble des acteurs

– Effectuer la mise à jour du Site Qualité

– Participer activement aux audits et inspections.

– Être fort de proposition pour effectuer de l’amélioration continue

– Etre l’interlocuteur pour le département affaires réglementaires

– Être un des garants du système qualité et aider au déploiement de ce dernier sur les filiales.

VOTRE PROFIL:

– Formation d’ingénieur ou pharmacien

– Expérience de minimum 4 ans dans le domaine des dispositifs médicaux ou en industrie pharmaceutique

– Expérience dans la qualité système

– Très bonne communication

– Anglais courant

– Être fort de proposition

Merci de faire parvenir votre CV à l’adresse mail crahmouni@axepta.com.

Coordinateur Post Market Surveillance

Notre client, une entreprise internationale spécialisée dans les dispositifs médicaux et en pleine croissance depuis plusieurs années,  recherche actuellement un Expert en Post Market Surveillance afin d’agrandir son équipe dans le cadre d’une forte croissance.

Vos responsabilités:

  • Etre responsable des données Post Market Surveillance au sein des départements de production, des affaires réglementaires, de la qualité, des recherches cliniques et du marketing
  • Faire le lien entre le département Sécurité et les autres départements de la societe (R&D, Clinique, Marketing, Affaires réglementaires et Qualité)
  • Participer au développement et aux audits
  • Rassembler et favoriser les données relatives au post market surveillance
  • Développer les actions PMS et les différentes études
  • Gérer le site de surveillance des autorités nationales de santé dont les FSA (Field Safety Action)
  • Etre garant  de la documentation scientifique (performance et sécurité vs concurrents)
  • S’assurer de la mise à jour et du respect des procédures post marketing et de la bonne documentation
  • Gérer et anticiper les risques en lien avec les procédures de plaintes des clients
  • Développer les procédures de gestion de risques avec les interlocuteurs
  • Participer aux divers comités

Votre profil :

  • Titulaire d’un master ou bachelor avec une expérience de 5 ans minimum
  • Connaissance et expérience dans les dispositifs médicaux
  • Compétences en système qualité et gestion des risques
  • Français et Anglais courants
  • Bonne communication orale et écrite

Merci de m’envoyer votre CV à crahmouni@axepta.com

Cabinet AXEPTA, Chayma RAHMOUNI

Expert Post Market Surveillance

My client is an innovating, dynamic and growing international medical device company currently expanding their clinical team in Switzerland, Geneva aera.

Due to this growth my client is looking for a PMS Specialist (new position).

YOUR RESPONSIBILITIES:

  • Act as interface between product surveillance and regulatory, Quality, Clinical R&D, and Marketing team to gather appropriately PMS data.
  • Ensure the interface between the Safety department and other services within the company (R&D, Clinical, Marketing, Regulatory Affairs and Quality)
  • Participate in the development of cross-functional document planning and review meetings
  • Collect, trend and escalate data related to Post marketing Surveillance
  • Develop PMS plans, PMCF plans, PSURs, and PMCF reports
  • Participate to the development of the CER
  • National health authorities website surveillance, including FSA (Field Safety Action)
  • In charge of the Scientific literature intelligence (performance and safety vs competitors)
  • Ensure that post marketing procedures, processes and documentation meet the regulations
  • Participation in the activities of risk management in connection with the customer complaint process (map, tables and risk management)
  • Develop the risk management process with R&D-CA-RA-MA interfaces, and user table point of contact
  • Participation on various committees (Change Board, CAPA Board, Risk Board, Quality Committee)
  • Follow-up to the NCF, changes and CAPA in connection with medical affairs

YOUR PROFILE:

  • Bachelor or Master with minimum 6 years in a similar position
  • Experience in the Medical Device industries
  • QSM and risk management skills
  • French and English, another language an asset
  • Good writing and communication skills

Please feel free to contact me at crahmouni@axepta.com

Expert Assurance Qualité Système

Notre client, une entreprise internationale spécialisée dans les dispositifs médicaux et en pleine croissance depuis plusieurs années,  recherche actuellement un Ingénieur Assurance Qualité Système afin d’agrandir son équipe qualité dans le cadre d’une forte croissance.

VOS MISSIONS:

– Être garant des diverses projets dans le département Assurance Qualité

– Travailler les processus CAPA, Analyses de Risques en lien avec l’ensemble des acteurs

– Effectuer la mise à jour du Site Qualité

– Participer activement aux audits et inspections.

– Être fort de proposition pour effectuer de l’amélioration continue

– Etre l’interlocuteur pour le département affaires réglementaires

– Être un des garants du système qualité et aider au déploiement de ce dernier sur les filiales.

VOTRE PROFIL:

– Formation d’ingénieur ou pharmacien

– Expérience de minimum 4 ans dans le domaine des dispositifs médicaux ou en industrie pharmaceutique

– Expérience dans la qualité système

– Très bonne communication

– Anglais courant

– Être fort de proposition

Merci de faire parvenir votre CV à l’adresse mail crahmouni@axepta.com.

PMS Specialist

My client is an innovating, dynamic and growing international medical device company currently expanding their clinical team in Switzerland, Geneva aera.

Due to this growth my client is looking for a PMS Specialist (new position).

YOUR RESPONSIBILITIES:

  • Act as interface between product surveillance and regulatory, Quality, Clinical R&D, and Marketing team to gather appropriately PMS data.
  • Ensure the interface between the Safety department and other services within the company (R&D, Clinical, Marketing, Regulatory Affairs and Quality)
  • Participate in the development of cross-functional document planning and review meetings
  • Collect, trend and escalate data related to Post marketing Surveillance
  • Develop PMS plans, PMCF plans, PSURs, and PMCF reports
  • Participate to the development of the CER
  • National health authorities website surveillance, including FSA (Field Safety Action)
  • In charge of the Scientific literature intelligence (performance and safety vs competitors)
  • Ensure that post marketing procedures, processes and documentation meet the regulations
  • Participation in the activities of risk management in connection with the customer complaint process (map, tables and risk management)
  • Develop the risk management process with R&D-CA-RA-MA interfaces, and user table point of contact
  • Participation on various committees (Change Board, CAPA Board, Risk Board, Quality Committee)
  • Follow-up to the NCF, changes and CAPA in connection with medical affairs

YOUR PROFILE:

  • Bachelor or Master with minimum 6 years in a similar position
  • Experience in the Medical Device industries
  • QSM and risk management skills
  • French and English, another language an asset
  • Good writing and communication skills

Please feel free to contact me at crahmouni@axepta.com

Quality Project Manager

Notre client, une entreprise internationale spécialisée dans les dispositifs médicaux et en pleine croissance depuis plusieurs années recherche actuellement un Ingénieur Assurance Qualité afin d’agrandir son équipe qualité dans le cadre d’une forte croissance.

 

Ce poste évoluera dans le temps au niveau des missions et selon les besoins grandissant de la société.

 

 

VOS MISSIONS:

– Être le garant de la mise en place de la nouvelle réglementation MDR au sein du département qualité.

– Travailler en étroite collaboration dans le cadre de la mise en place de cette réglementation.

– Effectuer un suivi quotidien des actions mise en place dans le cadre de la réglementation MDR.

– Participer activement aux audits et inspections.

– Être fort de proposition pour effectuer de l’amélioration continue

– Gérer différent projet qualité

– Être un des garants du système qualité et aider au déploiement de ce dernier sur les filliales.

 

VOTRE PROFIL:

– Ingénieur ou pharmacien avec une expérience de minimum 4 ans dans le domaine des dispositifs médicaux.

– Une bonne connaissance de la nouvelle réglementation MDR serait un plus

– Expérience dans la gestion de projet et en amélioration continue

– Très bonne communication

– Anglais courant

– Être fort de proposition

Pour plus de renseignements, merci de contacter Marine Dollat sur mdollat@axepta.com

Responsable Qualité Fournisseurs

Notre client, une entreprise internationale spécialisée dans les dispositifs médicaux et en pleine croissance depuis plusieurs années,  recherche actuellement un Responsable Assurance Qualité Fournisseur  afin d’agrandir son équipe qualité dans le cadre d’une forte croissance.

Ce poste évoluera dans le temps au niveau des missions et selon les besoins grandissant de la société.

 

VOS MISSIONS:

– Être garant des diverses projets dans le département Assurance Fournisseur

– Qualification fournisseurs et opérateurs Economiques et Réclamations fournisseurs

– Mettre en place la nouvelle réglementation MDR pour les opérateurs économiques

– Participer activement aux audits de qualification et approuver les changes controls

– Être fort de proposition pour fournir une expertise sur les questions de qualité fournisseur

– Etre acteur de son domaine pour fournir une amélioration continue des processus

– Être un des garants du système qualité et aider au déploiement de ce dernier sur les filiales

– Déplacements fréquents chez les distributeurs et au niveau des filiales

 

VOTRE PROFIL:

– Formation d’ingénieur ou pharmacien

– Expérience de minimum 5 ans dans le domaine des dispositifs médicaux ou en industrie pharmaceutique

– Expérience dans la qualité fournisseur

– Très bonne communication

– Anglais courant

– Être fort de proposition

 

Merci de faire parvenir votre CV à l’adresse mail crahmouni@axepta.com.

Expert Qualité Système

Notre client, une entreprise internationale spécialisée dans les dispositifs médicaux et en pleine croissance depuis plusieurs années,  recherche actuellement un Ingénieur Assurance Qualité Système afin d’agrandir son équipe qualité dans le cadre d’une forte croissance.

Ce poste évoluera dans le temps au niveau des missions et selon les besoins grandissant de la société.

 

VOS MISSIONS:

– Être garant des diverses projets dans le département Assurance Qualité

– Travailler les processus CAPA, Analyses de Risques en lien avec l’ensemble des acteurs

– Effectuer la mise à jour du Site Qualité

– Participer activement aux audits et inspections.

– Être fort de proposition pour effectuer de l’amélioration continue

– Etre l’interlocuteur pour le département affaires réglementaires

– Être un des garants du système qualité et aider au déploiement de ce dernier sur les filiales.

 

VOTRE PROFIL:

– Formation d’ingénieur ou pharmacien

– Expérience de minimum 3 ans dans le domaine des dispositifs médicaux ou en industrie pharmaceutique

– Expérience dans la qualité système

– Très bonne communication

– Anglais courant

– Être fort de proposition

 

Merci de faire parvenir votre CV à l’adresse mail crahmouni@axepta.com.

Global Medical Marketing Manager – Dermatology

My client is an innovating, dynamic and growing international pharmaceutical and consumer care company currently expanding their global Marketing team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Medical Marketing Manager with good experience in communication with Healthcare providers especially with skincare.

In this challenging and dynamic role, you will contribute to change the way the world thinks about skincare by leading the development of Global healthcare professional strategies.

You will play a key role to strengthen the understanding among healthcare professionals on what skincare products can do to improve the health of the skin of their patients/customers.

 

 

Responsibilities:

  • Will lead the development of the Global HCP strategy, Global communication campaigns for healthcare professionals as well as scientific communication to be delivered to markets.
  • Will provide expert scientific dermatology knowledge to develop new products as well as compelling science-based communication messages.
  • Deliver knowledge with support and alignment of Medical Expert and Claim Coordinator (CM): Own the HCP section in the SWOT analysis and in the brand innovation strategy and implementation, deliver scientific rationale behind consumer concepts and Claims, Integrate and align scientific inputs from local markets
  • Lead the development of the HCP strategy and toolkit (with the input of experts): manage agencies from start to finish, Gather inputs from relevant stakeholders throughout the process, Perform toolkit deployment and train the local Medical affairs or local representatives, Organize scientific/medical expert meetings with the participation of Medical Expert and Claim manager
  • Set up, leading and delivering scientific communication in partnership with CM and Medical Expert (posters, publications)
  • Member of project team: Provide HCP inputs whenever required and represent Scientific and Medical voices in the project team. Coordinate cross functional alignment with local Medical Affairs, Global Clinical Operations, Medical Expert
  • Lead and coach global brand manager(s); implement all people related processes (performance management, talent selection and development, compensation review etc.) to develop and reward direct reports
  • Represent brand with HCPs during congresses, symposiums, etc.

 

 

Your profile:

  • Nutritionist / Dermatologist / pharmacist background with master in Marketing
  • More than 10 years’ experience in HCP marketing management in the FMCG/FMCH industry in cosmetics / dermatology and matrix organization at a local, regional and global level
  • Successful track record of working in a matrix organization and managing diverse teams.
  • Thought leader in turning medical concepts / stories & claims into HCP and consumer centric concepts and claims to help support business initiatives
  • Thought leader in building strategies and assets to drive connectivity with target consumers via HCP influencers (from KOL to pharmacy assistant)
  • Combination of consumer centric business acumen and scientific savviness
  • Proficiency in English

 

For more details, please contact Jean de La Fournière at jean@axepta.com

Affaires Réglementaires Cosmétique Senior

 

My client is an innovating, dynamic and growing international consumer care company currently expanding their global clinical team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Senior Cosmetics RA Manager to plan and manage overall regulatory affairs strategy.

 

You will contribute to the global coordination of cosmetics for regulatory aspects for worldwide registration

 

Duties and Responsibilities

  • Setting up the regulatory strategy for projects under development
  • Contribute to defend RA strategy in dedicated forum
  • Cooperate with affiliates in order to perform a feasibility analysis of projects roll out WW based on regional/national regulations
  • Coordinate the preparation and participate to meetings with Health Authorities/Notified Bodies if necessary
  • Communication of project relevant RA information to Project Team and Department Heads
  • Represent RA for cosmetics in global & cross functional meetings
  • Provide regulatory support to ensure the content of dossier/PIF is compliant with relevant regulations and is sufficient for submission/notification
  • Update PIF periodically or upon specific request
  • Ensure regulatory support for new product launch
  • Maintain and track RA activities databases
  • Support the development of labelling and artworks for cosmetics
  • Act as deputy RA Head upon request

 

Work Experience           

 

  • 7 years min. of prior experience in global Regulatory Affairs in the Consumer Care environment
  • Mature interpersonal, communication and organizational skills.

 

 

Education and Training                               

 

  • Master or any equivalent advanced scientific degree in a related technical field.
  • Strong knowledge of the pharmaceutical & cosmetic industry, including solid knowledge of all associated global RA regulations.

 

Please send your CV in English to Jean de La Fournière at jean@axepta.com

Ingénieur Assurance Qualité – Pharmaceutique

My client is a growing pharmaceutical company based in the French part of Switzerland looking to expand their quality team.

Due to this growth, my client is looking for a Quality Assurance engineer with strong experience in design, qualification and validation to join their team.

 

 

Responsibilities:

•  Commissioning and Qualification of the utilities and process equipment.
•  Act as the point of contact for quality compliance topics regarding Process Equipment
•  Risk assessment exercises
•  Review and approve Process Equipment to ensure compliance with cGMP and applicable regulations
•  Support the Commissioning & Qualification activities during FAT at suppliers and on site
•  Create SOPs for Process Equipment qualification / validation
•  Conduct supplier’s audit as well as self-inspections
•  Ensure qualification and validation of all equipment in close collaboration with process engineering & automation teams
Your Profile:

•  Fluent in English and French
•  minimum of 5 years in a quality assurance engineering role in a manufacturing environment
•  Knowledge of biotechnological technologies
•  Proficiency in good practice requirements GMP as well as regulations and standards related to qualification and validation
•  Experience in health authorities inspections
•  Strong result orientation and committed team member
•  Flexibility and ability to travel up to 25% during project
•  Strong experience of Quality Assurance engineering and specifically on qualification and validation activities

Please send your CV in English to Jean de La Fournière at jean@axepta.com

Ingenieur Assurance Qualité – Project Manager

Notre client, une entreprise internationale spécialisée dans les dispositifs médicaux et en pleine croissance depuis plusieurs années,  recherche actuellement un Ingénieur Assurance Qualité afin d’agrandir son équipe qualité dans le cadre d’une forte croissance.

Ce poste évoluera dans le temps au niveau des missions et selon les besoins grandissant de la société.

 

VOS MISSIONS:

– Être le garant de la mise en place de la nouvelle réglementation MDR au sein du département qualité.

– Travailler en étroite collaboration dans le cadre de la mise en place de cette réglementation.

– Effectuer un suivi quotidien des actions mise en place dans le cadre de la réglementation MDR.

– Participer activement aux audits et inspections.

– Être fort de proposition pour effectuer de l’amélioration continue

– Gérer différents projets qualité

 

VOTRE PROFIL:

– Ingénieur ou pharmacien avec une expérience de minimum 4 ans dans le domaine des dispositifs médicaux.

– Une bonne connaissance de la nouvelle réglementation MDR

– Expérience dans la gestion de projet et en amélioration continue

– Très bonne communication

– Anglais courant

– Être fort de proposition

 

Merci de faire parvenir votre CV à l’adresse mail crahmouni@axepta.com.

Senior Regulatory Affairs Manager – Cosmetics

My client is an innovating, dynamic and growing international consumer care company currently expanding their global clinical team in Switzerland, Vaud Canton.
Due to this growth my client is looking for a Senior Cosmetics RA Manager to plan and manage overall regulatory affairs strategy.

You will contribute to the global coordination of cosmetics for regulatory aspects for worldwide registration

Duties and Responsibilities
• Setting up the regulatory strategy for projects under development
• Contribute to defend RA strategy in dedicated forum
• Cooperate with affiliates in order to perform a feasibility analysis of projects roll out WW based on regional/national regulations
• Coordinate the preparation and participate to meetings with Health Authorities/Notified Bodies if necessary
• Communication of project relevant RA information to Project Team and Department Heads
• Represent RA for cosmetics in global & cross functional meetings
• Provide regulatory support to ensure the content of dossier/PIF is compliant with relevant regulations and is sufficient for submission/notification
• Update PIF periodically or upon specific request
• Ensure regulatory support for new product launch
• Maintain and track RA activities databases
• Support the development of labelling and artworks for cosmetics
• Act as deputy RA Head upon request

Work Experience
• 7 years min. of prior experience in global Regulatory Affairs in the Consumer Care environment (OTC drugs/Cosmetics/Medical devices)
• Mature interpersonal, communication and organizational skills.

Education and Training
• Master or any equivalent advanced scientific degree in a related technical field.
• Strong knowledge of the pharmaceutical & cosmetic industry, including solid knowledge of all associated global RA regulations.

 

Please send your CV to Jean de La Fournière at jean@axepta.com

Regulatory Information Management System Manager (RIMS)

 

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton. Due to this growth my client is looking for a Regulatory Information Management System Manager (RIMS).

 

Responsabilities:

  • Maintain RIMS in a compliant and validated state
  • Provide direction and best practices to external provider
  • Establish and coordinate training strategy for end users
  • Interface with Operations to assure data sharing with ERP systems
  • Establish KPIs to measure RIMS data quality/usage
  • Keeping up to date with changes in regulatory legislation and guidelines
  • Optimize and simplify the process of handling and tracking post approval changes transformation project
  • Maintain SOPs, instructions … related to RIMS.
  • Propose/implement process improvements

 

Requirement:

  • Regulatory affairs processes and EU registration procedures
  • Regulatory Information Management systems (Register™ preferred)
  • 5+ years of prior regulatory experience
  • Ability to grasp new concepts quickly and to assimilate and evaluate scientific data
  • Strong IT skills, particularly in relation to using databases
  • Fluency in English

Ingénieur Assurance Qualité

Notre client, une entreprise internationale spécialisée dans les dispositifs médicaux et en pleine croissance depuis plusieurs années recherche actuellement un Ingénieur Assurance Qualité afin d’agrandir son équipe qualité dans le cadre d’une forte croissance.

 

VOS MISSIONS:

– Être le garant de la mise en place de la nouvelle réglementation MDR au sein du département qualité.

– Travailler en étroite collaboration dans le cadre de la mise en place de cette réglementation.

– Effectuer un suivi quotidien des actions mise en place dans le cadre de la réglementation MDR.

– Participer activement aux audits et inspections.

– Être fort de proposition pour effectuer de l’amélioration continue

– Gérer différent projet qualité

 

VOTRE PROFIL:

– Ingénieur ou pharmacien avec une expérience de minimum 3 ans dans le domaine des dispositifs médicaux.

– Une bonne connaissance de la nouvelle réglementation MDR serait un plus

– Expérience dans la gestion de projet d’amélioration continue

– Très bonne communication

– Anglais courant

– Être fort de proposition

 

Pour plus de renseignement, merci de contacter Marine Dollat sur mdollat@axepta.com

Senior Clinical Project Manager – Pharma – English Fluent – Vaud canton

My client is an innovating, dynamic and growing international pharmaceutical and consumer care company currently expanding their global clinical team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Senior Clinical Project Manager to plan and manage overall clinical operations for assigned global clinical trials/programs.

You will serve as a project team member and coordinate the overall clinical program activities with other functions (e.g. RA, CMC) including long-term, next stage planning and may supervise other CPMs as part of the overall clinical program.

 

Activities and responsibilities:

Plan and conduct Clinical Studies:

  • Responsible for leading and managing the multidisciplinary Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices.
  • Responsible for the development of the Clinical Trial Outline and Clinical Protocol.
  • Ability to manage complex phase 3 clinical trial programs.
  • Manages selection of study vendors for assigned studies.
  • Manages vendor(s) throughout the life of assigned clinical trial(s).
  • Selects investigational sites with input from Clinical Development and vendors.
  • Reviews and refines Clinical Operations Plans including monitoring and other plans.
  • Works with clinical supplies to determine IP requirements.
  • Works with operations to oversees investigative sites’ adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel & CRAs.
  • Provide input and contribute to the other study related documents.
  • Works with outsourcing manager and clinical team to establish budget and timelines for the study.
  • Plans and conducts investigator meetings, training sessions and KOL meetings as required.
  • Review clinical regulatory documentation for the study submission including but not limited to CTA modules, IB, IMPD, EC, safety reports, labels.
  • Works with CS, ME and project team as appropriate to develop the Clinical Study Report.
  • Identifies and provides solutions to clinical trial issues or risk.
  • Provide input together with the Clinical Project Team on responses to Health Authority questions and/or Ethic Committee/IRB.
  • Mentors staff and serves as a resource for new employees.
  • Provides or facilitate training to clinical study teams on protocol specific topics.
  • Participates as appropriate in internal and external audits.
  • Manages communication of study status and guidance to internal stakeholders.
  • Manage the Clinical Trial registry (clinical.trial.gov).
  • Manage the lesson learn meeting.
  • Manage subcontractors (CROs, experts …):
  • Works with Outsourcing manager to prepare Clinical outsourcing specifications.
  • Participate in the selection of CRO.
  • Review the CRO contract including scope of services.
  • Supervise adherence to scope of work within timelines and budget.

Quality and process:

  • Contribute and initiate process improvement initiatives.
  • Collaborate with other department members to promote harmonization of all processes and procedures.
  • Involve in documents quality control.

Budget and planning:

  • Establish project milestones and establish budget and timelines for the study conduct together with the study team.
  • Establish a detailed planning of clinical project.
  • Build, follow-up and close out study Budget following internal templates and instructions and according to the initially approved budget.
  • Follow-up closely the recruitment rate of the study and take appropriate corrective actions, if needed.
  • Make a risk assessment of the study and update it on a regular basis.
  • Track all aspects of the Clinical Trial and make regular progress reports.
  • Develop communication through newsletters to inform investigators and/or affiliates.
  • On a regular basis, update management with project milestones, costs, and projections for future activity (be able to provide various scenario/proposal/actions)

Project Team Representative (PTR):

  • Participate in the overall project planning, optimization and consolidation with the Project Team.
  • Works closely with the Medical Experts and Clinical Scientist for the design of the clinical trials within the Project.
  • Report progress on deliverables to the Project Team and identify variances and present solutions/alternatives.
  • Responsible and accountable for Operational aspects of the clinical project in terms of timelines, costs and resources.
  • Proactively evaluates risks at operational level and builds alternatives or contingency plans for discussion and arbitration within the Project Team.

Expected qualifications:

  • University degree, preferably in a biologic/scientific discipline
  • Minimum of 10 years progressive experience in clinical operations including 5 years of clinical project management or equivalent with Pharma/Biotech and/or CRO
  • Systemic route of administration clinical trials experience required; paediatric, drug/device combination and biologics experience preferred.
  • Thorough understanding of country level regulations, ICH and GCP guidelines, cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.
  • Ability to travel 30%

 

Please send your CV to Jean de La Fournière: jean@axepta.com

Senior Clinical Research Associate – English fluent – Pharma – Vaud

My client is an innovating, dynamic and growing international pharmaceutical and consumer care company currently expanding their global clinical team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Senior Clinical Research Associate has responsibility for the delivery of the studies at allocated investigator sites and is an active participant in the local study teams. You will work in close collaboration with other CRAs and the Local Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You may oversee regular CRA activities including contract CRAs.

 

Summary of responsibilities:

  • Oversees clinical trial set up including site selection and set-up.
  • Coordinates the overall interaction with clinical study sites and monitor CROs/site activities.
  • Key contributor to site identification and site selection.
  • Manages site closure activities of assigned sites with CRO.
  • Ensures quality and compliance with relevant regulatory standards according to procedural documents, international guidelines such as ICH and GCP as well as relevant local regulations.
  • Monitors sites or oversee monitoring activities by CROs to ensure quality and timeliness.
  • Ability to manage a phase 1 or small phase 2 clinical trial.
  • Review protocol for operational feasibility and organize feasibility studies to ensure appropriate country selection.
  • Lead and coordinate the selection of investigators and ensure that the appropriate selection process has been utilized.
  • In collaboration with the CPM, make recommendations for the appropriate outsourcing of any required functions (e.g. monitoring, laboratory services etc.) and participate in the preparation of the related documentation.
  • Assist the CPM with the preparation of bid grids, budgets and significant study milestones.
  • Establish country and/or site-specific recruitment targets with internal / External CRAs and CPM to meet timelines.
  • In collaboration with line function manager and CPM, participate in CRO and other third-party vendor selection; assist with the review of proposals and attend bid defenses as required.
  • Development and/ or review of assigned study documentation (e.g. Protocol, ICF, Monitoring Plan, eCRFs).
  • Coordinate and/or organize technical training at investigator meetings, CRO/CRA training meetings.
  • Ensure that all regulatory approvals have been obtained before initiation visits are conducted & that the appropriate documentation is available.
  • Ensure that appropriate documentation is available to the investigators in a timely manner.
  • Ensure that clinical trial supplies are made available to investigators along with any other materials required by the protocol.
  • Participate in the set-up & user testing (UAT) of any systems used during a study e.g. eCRF/EDC, IRT, central laboratory portals etc. This includes review of relevant vendor documentation (system specifications, validation etc.).
  • Manage, track and document CRO CRA activities by reviewing monitoring reports, tracking on-site visit frequency, organization of on­ site quality control visits as appropriate.
  • Be responsible for and hold CROs accountable for contracted tasks relating to data monitoring and site quality.
  • Track recruitment and take appropriate steps to ensure recruitment targets are met; ensure Clinical Project Manager is fully informed & collaborate with CPM to identify issues, trends, resolutions and/or corrective actions.
  • Track, measure and report any deviations versus the planned timetable; identify the causes and provide solutions.

 

Work Experience:

  • Minimum of 5 years progressive relevant clinical experience in clinical operations including 3 years as Clinical Research Associate or equivalent with Pharma/Biotech and/or CRO.
  • Drug/device combination and biologics experience preferred.
  • Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
  • Excellent knowledge of relevant local regulations.
  • Good understanding of the drug development process.
  • Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.

 

Education/Training:

University degree, preferably in life sciences or equivalent qualification

Please send your CV to Jean de La Fournière: jean@axepta.com

Medical Marketing Manager

Senior HCP Marketing Manager

My client is an innovating, dynamic and growing international pharmaceutical and consumer care company currently expanding their global Marketing team in Switzerland, Vaud Canton.
Due to this growth my client is looking for a Senior HCP Marketing Manager with good experience in communication with Healthcare providers especially with skincare.
In this challenging and dynamic role, you will contribute to change the way the world thinks about skin health by leading the development of Global healthcare professional strategies.
You will play a key role to strengthen the understanding among healthcare professionals on what skincare products can do to improve the health of the skin of their patients/customers.

Responsibilities:
• Will lead the development of the Global HCP strategy, Global communication campaigns for healthcare professionals as well as scientific communication to be delivered to markets.
• Will provide expert scientific dermatology knowledge to develop new products as well as compelling science-based communication messages.
• Deliver knowledge with support and alignment of Medical Expert and Claim Coordinator (CM): Own the HCP section in the SWOT analysis and in the brand innovation strategy and implementation, deliver scientific rationale behind consumer concepts and Claims, Integrate and align scientific inputs from local markets
• Lead the development of the HCP strategy and toolkit (with the input of experts): manage agencies from start to finish, Gather inputs from relevant stakeholders throughout the process, Perform toolkit deployment and train the local Medical affairs or local representatives, Organize scientific/medical expert meetings with the participation of Medical Expert and Claim manager
• Set up, leading and delivering scientific communication in partnership with CM and Medical Expert (posters, publications)
• Member of project team: Provide HCP inputs whenever required and represent Scientific and Medical voices in the project team. Coordinate cross functional alignment with local Medical Affairs, Global Clinical Operations, Medical Expert
• Lead and coach global brand manager(s); implement all people related processes (performance management, talent selection and development, compensation review etc.) to develop and reward direct reports
• Represent brand with HCPs during congresses, symposiums, etc.

Your profile:
• Nutritionist / Dermatologist / pharmacist background with master in Marketing
• More than 10 years experience in HCP marketing management in the FMCG/FMCH industry in cosmetics / dermatology and matrix organization at a local ,regional and global level
• Successful track record of working in a matrix organization and managing diverse teams.
• Thought leader in different lifecycles of brands (incl. ideation, launch and sales)
• Thought leader in turning medical concepts / stories & claims into HCP and consumer centric concepts and claims to help support business initiatives
• Thought leader in building strategies and assets to drive connectivity with target consumers via HCP influencers (from KOL to pharmacy assistant)
• Combination of consumer centric business acumen and scientific savviness
• Proficiency in English

For more details, please contact Jean de La Fournière mailto:jean@axepta.com

Pharma Regulatory Affairs Submission Associate

 

Core Mission

To support the Regulatory Affairs Submissions team in the frame of new registrations and maintenance of the registered products (prescription drugs) mainly for international countries (excluding US) and  ad-hoc support for European countries.

 

Activities and responsibilities

  • Coordinate the constitution and/or tracking of registration, variation or renewal dossiers
  • Assure timely receipt and dispatch of administrative documents and their legalization (if applicable) necessary for registration, renewal and variation files (including but not limited to Certificate of Pharmaceutical Products, Free Sale Certificates, Letter of Authorization, GMPs, Price certificates)
  • Support the team in terms of uploading documentation in our EDMS system, put in place tracker for Regulatory Affairs Database update

 

Work Experience

  • 1-2  year’s experience in regulatory affairs, ideally in a global organization for international countries such as Middle East, CIS or Latin America
  • Experience in a multinational environment
  • Experience in the pharmaceutical industry and use of Electronic Document Management System, regulatory affairs database

 

Required Skills and Knowledge

  • BSc in Scientific or equivalent experience
  • Planning, organizing and time management skills
  • ability to deal with rapid change
  • Fluent in English; French and/or Spanish is a plus

Please send your CV to Jean de La Fournière at jean@axepta.com

Pharmaceutical Regulatory Affairs – Publishing specialist

An innovating, dynamic and growing international pharmaceutical company is currently expanding their regulatory team in Switzerland, Vaud Canton.

Due to this growth they are looking for a Regulatory Affairs Publishing and eCTD specialist to join them on a permanent contract.

Responsibilities:

  • Supporting Publishing and EDMS (Electronic Document Management System) users
  • Business Administrator for Publishing and EDMS systems
  • Archiving Submission Dossiers
  • Provide training and support for Publishing and EDMS users
  • Manage related training materials
  • Perform Business Administration activities for Publishing and EDMS
  • Archive Submission Dossiers and ensure their traceability across systems
  • Interface with Coordinators from Consumer and Aesthetic SIGs and with IT team
  • Support writing of procedures, instructions, user guides
  • Ad interim, could act as delegate of the Publishing coordinator for outsourced activities

Your profile:

  • BSc, MSc in scientific, IT or administrative discipline or equivalent experience
  • Minimum 3 years’ experience Pharmaceutical Industry
  • Minimum 2 years’ in similar role

Please send your application to Jean de La Fournière: jean@axepta.com