Author: Noemie Oliva

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 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 share your CV to Jean de La Fournière, jean@axepta.com

Senior Regulatory Affairs – 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 Regulatory Affairs Manager to plan and manage overall regulatory affairs projects.

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

Pharmaceutical Quality Assurance Engineer

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

Global Medical/Scientific Communications Manager

My client is a growing international biopharmaceutical company based in the French part of Switzerland with ongoing growth.

Due to this growth, my client is looking for Global Medical Communications/Scientific Communications Manager to join their growing Global Medical Affairs team.

Responsibilities:

  • Creation of Global Scientific Content, the provision of Global Medical Information as well as Global Medical Training services ensuring the timely and high-quality delivery of medical, scientific and technical information and data
  • Management of medical communication operations, such as development of electronic document repositories or global standard operating procedures (SOPs).
  • Ensuring high quality and expediency in the development and distribution of medical, scientific and technical information to both internal and external customers
  • Maintaining a high level of technical and scientific expertise through familiarity with medical and scientific literature on the Incyte pipeline asset
  • Contributing to the global medical strategy and ensuring execution of global medical communications activities in accordance with the departmental operational model and expectations while meeting appropriate legal, regulatory and corporate requirements
  • Engaging with other functions in developing, modifying and executing departmental and company procedures and policies that have immediate operational effect
  • Planning, developing and maintaining key medical information documentation, this includes but is not limited to Medical Information Response Letters, Questions & Answers documents, medical slide decks
  • Supporting the Global Medical Information Call Center through training, monitoring inquiries, and managing escalated inquiries ensuring prompt, accurate, quality-assured responses to medical/ scientific/ technical information requests from healthcare professionals, patients, caregivers, and the general public
  • Participating in international medical & scientific congress activities, and developing congress materials (e.g. brochures, videos)
  • Developing training modules primarily for medical teams but also for the rest of the R&D organization.
  • Supporting the Medical Communications needs of regional and local affiliates and ensuring consistency of medical messaging across the globe by creating and maintaining effective communication channels, facilitating training, and providing access to key scientific documents.
  • Participating in development and maintenance of standard operating procedures (SOPs) for Global Medical Content Creation and Review, as well as Global Medical Information Services

 

Your profile:

 

  • Advanced degree in Life Sciences (e.g., Ph.D.) or Pharmacy sciences (e.g., Pharm.D.), or equivalent is required
  • Minimum 3-5 years’ experience in the field of Scientific Content, Medical Information and/or Communications is a must
  • Experience in medical scientific exchange (e.g., MSL slide decks) material management and execution at a global level
  • In-depth understanding of legal requirements, regulatory issues, codes of practice and guidelines as relevant to the provision of Medical Information and medical data communication and scientific exchange
  • Must be fluent in English, other languages is an asset

Please send your CV to noliva@axepta.com 

 

 

 

Senior Analytical Scientist Oral and Topical Form

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

 

Due to this growth my client is looking for a Senior Analytical Scientist with experience working on Oral and Topical forms.

 

Responsibilities:

 

  • Contribute to design and oversee Small Molecule, oral and topical, analytical development plan and stability programs, any applicable regulatory requirements.
  • Contribute to design and oversee scientific studies in support of technical programs as they progress from early development into confirmatory development, technology transfer up to the registration and to support as needed manufacturing process at the commercial site.
  • Outsourcing of key activities such as drug substance characterization, method development/optimization/validation/transfer, proposing specification and analytical control strategies, recommending stability programs.
  • Design stability program in close cooperation with Internal Experts and external partners
  • Contribute to analytical development plan and stability program for primarily Drug Substance and possibly Drug Product in cooperation with external partner and internal experts, in line with business priorities, following a Quality by Design framework
  • Solve complex problems (e.g. deviations, OOS) through collaborations with others
  • Review, author and approve key documents such as method development reports, validation protocols/reports, and justification of specifications, stability protocols/reports and relevant sections of regulatory filings (DMF, IND, IMPD, NDA etc.)
  • Apply broad and deep analytical knowledge and experience to the analytical development and characterization of drug substances and powder
  • Ensure close oversight of GMP activities that are conducted externally to ensure at each stage of development an appropriate level of quality requirements and report in a timely manner any major or critical issue
  • Maintain awareness of cutting-edge and specific technologies in the field of small molecule and ensure knowledge acquisition

 

Your profile:

  • PhD with 5 years of working experience or MS with 15 years of working experience in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or closely related to the field
  • Strong track record of success with oral and topical developments
  • Experience working with external partners (e.g. CDMO, CRO, Academic)
  • In-depth scientific knowledge and experience in developing and validating analytical methods, covering different technics and methods (e.g. microscopy (SEM, TEM, SEM-EDX, ATR-FTIR), spectroscopy (FTIR, Raman, confocal RAMAN, UV-vis), laser scattering and solid-state characterization techniques (XRPD, DSC, TGA, ITC), powder rheology, surface area determination by BET, particle size and particle shape and morphology techniques
  • Solid understanding of characterization, technology transfer and troubleshooting when it comes to drug substances (Oral and Topical)
  • Fluency in English, both spoken and written, any other language an asset

Please send your profile to noliva@axepta.com 

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 : jean@axepta.com

Senior Clinical Project Manager – Pharma – English Fluent – 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 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

Senior Healthcare Marketing Manager – English fluent

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 jean@axepta.com

Pharma – Regulatory Affairs RA 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 Fournièere at jean@axepta.com

Head of Molecular Dermatology

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

 

Due to this growth my client is looking for a Head of Molecular Dermatology whom will be responsible for the strategy, conduct and interpretation of the Global Molecular Dermatology activities (genomics, proteomics, metabolomics, morphology and molecular histology, bioinformatics and biological interpretation) and translational activities necessary for identification, design and progression in development of future systemic (oral, biological) and topical drug candidates.

 

Responsibilities:

 

  • Contributes to define the future strategic areas of Research
  • Contributes to implement the Research Strategy in line with the overall strategy and implement the corresponding technological solutions.
  • Contribute, in cooperation with other functions of Research to the definition of biomarker strategy necessary for the preclinical and clinical evaluation of the targets
  • Contributes to the definition and implementation for each program of the necessary translational activities.
  • Proposes the strategy in Molecular Dermatology and associated bioinformatics activities in line with the global strategy
  • Contributes to the evaluation and prioritization of projects.
  • Defines the needs, selects and maintains a pool of CRO partners to conduct the Molecular Dermatology and associated bioinformatics activities needed to implement the strategy.
  • Organizes and directs the activities of Molecular Dermatology and associated bioinformatics in the Research and Development phase, necessary to ensure the clinical evaluation of a portfolio of innovative projects aligned with the strategy
  • Organizes and directs the interaction with the CRO partners for all Molecular Dermatology, bioinformatics and biomarker activities.
  • Contributes to the definition of the innovation strategy in the field of biology and participates in the implementation of the selected strategies.
  • Contributes to the identification, selection and management of strategic collaborations of the Research Department
  • Provides scouting, evaluation, and recommends opportunities for licensing and / or internalization of molecules and / or projects in the different phases of Research and Development.
  • Contributes to the management of the global research budget
  • Contributes to maximizing the value proposition of Research and Development projects.

 

 

Your profile:

 

  • PhD in general biology or PhD in a discipline of molecular biology (genomics, proteomics, metabolomics …) or equivalent.
  • Post-doctorate in an academic or industrial environment – preferably abroad.
  • Academic training or acquired through the experience of pharmacokinetics and pharmacology in vitro and in vivo.
  • Academic or experiential training in the drug discovery and development process and in particular in the development of oral small molecules and biologics (monoclonal antibodies etc.)
  • You have minimum 15 years of expertise in academic or industrial research in the field of in vitro and in vivo pharmacology associated with human health, of which an important part in the field of molecular biology (omics).
  • You have excellent knowledge of bio-marker approaches in clinical research.
  • You have demonstrated a successful experience conducting collaborative research programs with external partners.
  • You have good knowledge of skin biology and dermatological pathologies, immunology and biology of inflammatory processes of inflammation.
  • You have excellent knowledge of development processes and early clinical development in particular.
  • Excellent teaching and presentation skills are expected, as well as an excellent leadership capacity with a multicultural and multidisciplinary team.
  • You speak and write English fluently.

Please send application to noliva@axepta.com 

Clinical Post Market Surveillance – Medical Devices

Job Description

Responsiblities

  • 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
  • In connection to R&D and Clinical team,analyze, adapt and translate technical information related to products into medical information suitable for the marketing team
  • 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
  • Regulatory watch: PMS, clinical, MD vigilance,Medical Affairs
  • National health authorities website surveillance,including FSA (Field Safety Action)
  • In charge of the Scientific literature intelligence(performance and safety vs competitors)
  • Track competitors data performance (clinical studies) and safety (vigilance)
  • Ensure that post marketing procedures, processes and documentation meet the regulations in all subsidaries
  • 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 inconnection with medical affairs
  • Participation in the improvement of processes,procedures, instructions, forms, tools and database in relation to the activities of the Medical Affairs Department
  • Participation to Audits

Secondary activities:

  • Respect the safety rules and apply the instructions in force,
  • Report all situations of risk to her manager or co-workers,
  • Do not expose his colleagues in situations of danger,
  • Use the measures of protection of collective and individual required foractivity

 

KNOWLEDGES and SKILLS required:

Minimum level of training and/or professional experience required by the function:

  • Scientific training
  • Experience in the Medical Device industries
  • QSM and risk management skills
  • French and English, another language an asset
  • Good writing and communication skills
  • Control of Pack Office

Job Type: Full-time

Please send your application to Jean de La Fournière: 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

Clinical Trial Associate (CTA)

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

 

Due to this growth my client is looking for an experienced CTA to join them in Lausanne area.

 

Responsabilities :

  • The Clinical Trial Associate (CTA) is involved in the set up and follow-up of the studies, in the management of study documentation and actively supports the Clinical Research Associate (CRA) and Clinical Project Managers by creating, updating, distributing study materials, tools and documents.
  • Generate, finalise and distribute study team agenda and meeting minutes in a timely manner. Act as a support to the CPM for meeting preparation.
  • Verify vendor’s work order and create / update purchase orders accordingly, with confirmation from CPM.
  • Ensure review of study budget under responsibility of the CPM.
  • In case of short / unexpected absences of the CPM, systematically act as Backup and primary point of contact of the study by directing the action items to the most appropriate person.
  • Contribute to the quality of all activities and key steps of the clinical study deliverables, and the delivery of the clinical study according to the ICH GCP and local applicable regulations, and in accordance with SOPs.
  • Update and/or track study reporting tools

 

Your Profile :

 

  • University/College degree level or equivalent in a relevant discipline.
  • Proven track record of at least 2 years of experience as CTA or comparable operating experience in Pharma/CRO/healthcare with good knowledge of budget and invoicing requirement, as well as drug development process and medical terminology.
  • Experience in Management and filing of Trial Master File content
  • Excellent spoken and written English
  • Customer orientation and Team spirit, with ability to foster a collaborative team environment and to work effectively with others in a fast-paced matrix organization;
  • Ability to communicate with cross-functional teams.
  • Strong organizational skills with ability to manage stress, pressure and deadlines.
  • Good to advanced computer skills with requirement of MS applications.

Please send your CV to noliva@axepta.com

Associate Director Global Regulatory Affairs Oncology

My client is a growing international biopharmaceutical company based in the French part of Switzerland with ongoing growth.

Due to this growth, my client is looking for an Associate Director Global Regulatory Affairs with strong experience working at global level and Oncology.

Responsibilities:

 

  • Supports regulatory objectives, advice and strategy in alignment with department and corporate goals
  • Works with multi-functional teams to ensure that regulatory requirements for the assigned products are achieved.
  • Be the official liaison with European Regulatory Agencies and will support preparation and conduct of meetings with European Regulatory Agencies
  • Plans and manages regulatory document preparation for regulatory submissions in Europe and in International geographies including CTAs, MAAs, Variations, Orphan applications, PIPs.
  • Responsible for ensuring that the company is developing and executing optimal regulatory strategies for Europe and International geographies, and for preparing and supporting interactions with regulatory authorities appropriately
  • Develop and lead globally aligned regulatory strategies for novel small molecule and biologics.
  • Activities include Scientific Advice, Orphan Drug Designations, paediatric plans, registration procedures to optimize successful regulatory review and approval
  • Review and interpret regulatory correspondences for global project teams
  • Provide regulatory support to inter-departmental project teams and interact proactively with other functions, contract research organizations, partner companies, and health authorities
  • Work with global regulatory team to agree contents for timely submissions to Health Authorities
  • Plan and lead the preparation, review, and approval of compliant regulatory documents for European and International CTA and MAA submissions throughout the product lifecycle
  • Coordinate the preparation of responses to questions and inquiries from Health Authorities.
  • Prepare and submit CTA amendments, DSUR and MA Renewal in accordance with regulatory submission schedules and regulations.
  • Work with Regulatory Operations group to ensure preparation of dossiers containing preclinical, clinical, and technical data in the required eCTD format
  • Coordinate and support regulatory activities with affiliates and consultants including regulatory review of promotional materials by specific country RA affiliate/consultant
  • Contribute to improvements in department operating procedures

 

 

Your profile:

  • BS degree, preferably in a scientific discipline with a minimum of 8 years pharmaceutical / biotechnology experience and with a minimum of 5 years regulatory experience, preferably including one full submission or line extension through authorization
  • Experience in interactions with regulatory agencies.
  • Experience with clinical trial applications
  • Expert project management and interpersonal skills is a requirement, as well as excellent written and verbal communication ability
  • Experience in oncology and orphan products

Please send your CV to noliva@axepta.com

Experienced CRA

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

 

Due to this growth my client is looking for an experienced CRA to join them in Lausanne area.

 

Responsibilities:

•Oversees clinical trial set up including site selection and set-up.
•Coordinates the overall interaction with clinical study sites and monitors CROs/site activities.
•Monitors sites or oversee monitoring activities by CROs to ensure quality and timeliness.
•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.
•Identifies and qualifies clinical sites to ensure quality investigative sites.
•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.
•Establish country and/or site-specific recruitment targets with internal / External CRAs and CPM to meet timelines.
•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.

Your profile:

•University degree, preferably in life sciences or equivalent qualification.
•Minimum of 3 years progressive relevant clinical experience in clinical operations as Clinical Research Associate with Pharma/Biotech and/or CRO.
•Good knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
•Good knowledge of relevant local regulations.
•Basic understanding of the drug development process.
•Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
•Fluent in English

Please send your CV to noliva@axepta.com

Seniro Healthcare Professionals Marketing Manager (Skin Care)

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 care 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

Please send your CV to noliva@axepta.com 

Global Consumer Engagement Head

My client is an innovating, dynamic and growing international pharmaceutical and healthcare company currently expanding their Consumer Care strategic group based in Lausanne area.

 

Due to this growth of activities my client is looking for a Global Head of Consumer Engagement & Digital

 

Responsibilities:

 

Drive a consumer centricity mind-set throughout the whole consumer care business by:

·         leading the consumer engagement strategy at a global level for the Consumer Care Strategic brands.

·         driving and nurturing the relationship with agency partners that provide consumer engagement services

·         leading consumer engagement best practice & synergies across franchises and key markets, with focus on digital / social media.

·         mentoring and coaching the global marketing team and key market teams in use and delivery of engagement programs on a day-to-day basis as well as through the delivery of trainings programs, webinars and external speaker’s sessions.

·         Deliver the consumer engagement roadmap

·         Contribute to the development of consumer centric campaign Ideas / executions for the priority brands

·         Accountable for and co-Lead with marketing consumer engagement strategies and create attractive and rewarding brand experiences. This includes delivery of consumer communication channel and marketing investment guidelines and modular global toolkits / content to be leveraged locally

·         Works in partnership with communication agencies to ensure all brand communication contributes to positively enhancing consumer engagement into the brand

·         Identify opportunities for synergies across franchises and lead best practices deployment to help support execution in key markets

·         Contribute to the Development and updates of consumer portrait, consumer engagement funnel for the brands and other brand building initiatives with a view to activate the Brand Equity Model

·         Establish KPIs and Track / monitor the performance and health of these assets to improve them further and inform back the global strategy.

·         Closely collaborate with agency partners (eg. google, FB, Hogarth) to leverage necessary support (eg. foundational, analytics, and consumer engagement solutions critical for digital programs)

 

 

Your profile

 

·         Master degree or equivalence in communication / marketing

·         Minimum 7-10 years’ experience in Consumer engagement programs with specific focus on Digital in the FMCG industry and in a matrix organization at a global / regional level

·         Solid brand marketing as well as direct report management experience (3-5 years)

·         Thought leader in consumer communication channel and brand marketing investment strategies

·         Proven track record of turning analytics, consumer and market trends into strategies and initiatives to feed brand growth and equity

·         In depth experience in delivering complex consumer engagement projects, possessing a Strategic vision on building consumer engagement in brands

·         Strong communication skills, proficiency in English, any other language is an asset

Please send your CV to noliva@axepta.com

Global Strategic Marketing Manager-Oncology

My client is an innovating, dynamic and niche international biopharma company currently expanding their business development and commercial department.

Due to this growth my client is looking for a Global Marketing Strategic Manager with strong Oncology experience and pre-launch to join them in Lausanne area.

Responsibilities:

 

  • Responsible for building and integrating the Marketing strategy of oncology products into the company’s portfolio development plan in accordance with the company objectives.
  • Gather and analyse market insights covering key global markets.
  • Key contributor to the creation of market-driven products & disease area strategies, creating and refining target out-licensing profiles
  • Liaise with the communication team to identify communication needs and channels, creating opportunities to develop product awareness within target audiences
  • Support the licensing team with assessment of business opportunity for new products with Market Intelligence team
  • Build and implement advocacy plans in collaboration with Medical team
  • Optimize Target Product Profile (TPP) development, with clearly differentiated competitive advantage and value proposition ensuring consistency with TOP
  • Establish strong and productive relationship with key stakeholders and other team members
  • Work closely with agencies and Clinical Operations to speed up enrolment, increase visibility, and secure optimal enrolment and retention of on-going trials, designing and implementing recruitment campaigns to engage both investigators and patients.

 

Your profile:

  • Bachelor’s degree, in scientific or business discipline
  • Minimum 7-8 years experience in marketing in a large or mid-sized pharmaceutical company
  • In-line brand marketing experience in Oncology
  • Broad commercial experience including pre-launch
  • International experience, including US and Europe
  • Experience in leading and motivating agency partners to deliver high impact marketing and market shaping initiatives
  • Experience and knowledge of a broad base of external customers including patients, prescribers, payers, providers
  • Thorough understanding of product positioning, product plan and brand development processes and necessary commercial touch points

 Please send your application to noliva@axepta.com 

Head of Global Regulatory Affairs Skin Care/Cosmetics

My client is an innovating, dynamic and growing international pharmaceutical and healthcare company currently expanding their Global Regulatory Affairs team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Head of Global Regulatory Affairs with experience working on Skin Care/Cosmetics Products at global level including US and ASIAN market.

 

Responsibilities:

  • Ensure that regulatory strategy follows local and international regulatory requirements for skin care products and OTC products
  • Represent the company in Health Authorities ‘meetings
  • Lead and Manage a Regulatory Affairs team
  • Ensure professional development of individuals
  • Act as Global regulatory representative
  • Act as deputy RA Head upon request
  • Coordinate the writing and update of dossiers according to the current regulation
  • Bring strong expertise in regulatory affairs on cosmetics

 

Your profile:

  • Lifescience Degree, Master or any equivalent advanced scientific degree in a related technical field.
  • Minimum 10 to 15 years of Experience in global Regulatory Affairs with strong experience in the Consumer Care environment (Skin Care/Cosmetics).
  • Leadership, direct management, mature interpersonal, communication and organizational skills, direct and mobilize team around common goals and objectives, manage through efficient delegation, encourage and support individual’s development
  • Strong knowledge of the pharmaceutical & cosmetic industry, including solid knowledge of all associated global RA regulations.

Please send your application to noliva@axepta.com