Life Science

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 car 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 Marine Dollat at mdollat@axepta.com

Global Head of Digital Marketing & Consumer Engagement

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 Digital Marketing & Consumer Engagement

 

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

For more details, please contact Marine Dollat at mdollat@axepta.com

Pharmacovigilance Quality Assurance Support (60%)

My client is an innovating, dynamic and growing international CRO with key expertise in Clinical Trial, regulatory affairs and Pharmacovigilance currently expanding their Pharmacovigilance team in the French part of Switzerland.

Due to this growth of activities my client is looking for a Pharmacovigilance Quality Assurance Support (60%) for a contract of minimum 1 year.

 

YOUR RESPONSIBILITIES:

– Management of non-compliance and CAPA

– Establish PV audit planning, PV audit management and remote PV audit execution and reporting

– Support to PV SOP development and review

– Contribute the quality check of DSUR, PSUR, RMP, PSMF

 

YOUR PROFILE:

– Master degree or equivalence in pharmacovigilance.

– Minimum 3 years experience in pharmacovigilance and pharmaceutical company.

– Strong experience with aggregate reports and PV audits.

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

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

Clinical Project Manager

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

Due to this growth my client is looking for a clinical Project Manager who will be in charge of implementing clinical studies to ensure compliance with the European Medical Device Regulation and its recent updates .

YOUR RESPONSIBILITIES:

  • Manage and successfully completion of clinical research operations in clinical studies
  • Ensure that clinical studies are conducted in accordance with local regulations, GCP regulations, and internal SOPs,
  • Work closely with external partner (ie CROs)
  • Manage CROs and ensure adherence to scope of work within timelines and budget
  • Oversee high quality documentation (ie from study protocol to Clinical Study Report) throughout the clinical study is available
  • Management of clinical study budgets including site agreements/budget
  • Risk management handling
  • Establish co-monitoring visit to ensure monitor performance meets expectation
  • Ensure that all relevant documents are properly archived in the TMF during the study

YOUR PROFILE:

  • Minimum B.Sc. degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
  • Minimum of 2 years of experience in clinical operations (from startup to close-out); project management skills
  • Strong communication skills.
  • Quick learner to be autonomous quickly
  • Fluent in English and French

For more details, please contact Marine Dollat at mdollat@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 Packaging and Medical Device Technology Expert

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 senior packaging and medical device technology expert to provide to lead, design and oversee packaging and medical device technology strategy development.

 

Your responsibilities:

  • Lead and manage technical activities to address complex design, development, operational issues for the preparation and timely delivery of Primary and Secondary Packaging for combination products and topical delivery systems
  • Proposes the strategy for developing human factor engineering program for combination products
  • Contributes to develop early and late phase packaging and medical devices (e.g. delivery system for combination products)
  • Proactively contribute to implement regional regulatory requirements and guidelines that impact packaging and medical device activities in close cooperation with Pharmaceutical Development Expert
  • Interact closely with external partner to ensure selection of packaging and medical devices
  • Contributes to implement, with internal partners and external partners, scientific programs to ensure adequacy of the packaging and medical device solutions: leachable & extractible studies, shipment studies
  • Author, review and/or approve key documents such as development reports, validation reports, and relevant sections of regulatory filings (IND, IMPD, CTD)

 

Your profile:

 

  • PhD in Chemistry, Pharmaceutical Sciences, Pharmacist, MS in Chemical Engineering or closely related to the field with at least 10+ years of relevant experience in pharmaceutical/medical device industry
  • You have excellent knowledge of Established track record of success with combination products development programs
  • You have demonstrated a successful experience with external partners
  • You have excellent knowledge in developing primary and secondary packaging, medical devices
  • You have excellent knowledge of cGMP, 21CFR820, ISO13485, ICH guidance’s, ISO standards and applicable guidelines
  • You have demonstrated a successful experience related CMC sections of IND/IMPD and NDA/CTD/BLA regulatory submissions
  • You speak and write English fluently

 

For more details, please contact Marine Dollat at mdollat@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

Program Manager – Drug Development

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 Program Manager (drug development) to provide day-to-day project management leadership to global drug development project teams. He/she will maintain project plans and budgets, organize and lead project team meetings to meet goals.

YOUR RESPONSIBILITIES:

  • Bring strong expertise product development plans
  • Coordinates global, cross-functional, complex drug development project teams and provides advanced project management support, including action item tracking, organization and communication of materials.
  • Organizes interdepartmental activities to ensure completion of assigned projects within scope, on schedule and within budget constraints.
  • Identifies, monitors, and analyzes business project risks and prepares project planning contingency scenarios.
  • Ensures accurate tracking and reporting of project milestones and deliverables
  •  Identifies and communicates resource constraints to senior management.
  • Prepares project updates for governance meetings and clearly communicates status in written documents and presentations.
  • Ensures documentation of, and access to, key project documents, presentations and data.
  • Assumes full responsibility for managing specific aspects of the project as designated by team leadership

Expected qualifications:

  • Bachelor or PhD degree (MBA)
  • At least ten years of relevant experience in experience in a Biopharma or Biotech environment with and seven years in a similar position in Project Management
  • Thorough understanding of the drug development processes
  • Hands-on expertise with project management tools
  • Good understanding of financial and resource planning systems and processes and ability to coordinate project level budget/resource estimates and manage actuals vs. plan
  • Good communication
  • Fluent in English

For more details, please contact Marine Dollat at mdollat@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

Regulatory Affairs Submission Associate

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

Due to this growth my client is looking for a Regulatory Affairs Submission Associate with good experience in Electronic Document Management System.

In this challenging and dynamic role, you will support the Regulatory Affairs Submissions team in the frame of new registrations and maintenance of the registered products.

Regulatory Affairs Submission Associate

YOUR RESPONSIBILITIES:

  • Coordinate the constitution and/or tracking of registration, variation or renewal dossiers
  • Lead timely receipt and dispatch of administrative documents and their legalization necessary for registration, renewal and variation files 
  • Be an ad-hoc support for European countries
  • Work closely with the regulatory team to lead new registrations and maintenance of the registered products.
  • Support the team in terms of uploading documentation in our EDMS system, put in place tracker for Regulatory Affairs Database update.

 

YOUR PROFILE:

  • BSc in Scientific or equivalent experience with an experience of minimum 1-2 years in regulatory affairs, ideally in global organization for international countries.
  • Experience in a multinational environment
  • Experience in the pharmaceutical industry and use of Electronic Document Management System, regulatory affairs database
  • Fluent in English, Spanish is a plus

Clinical Data Manager

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

Due to this growth my client is looking for a Clinical Data Manager.

Your Responsibilities :

 

– Contribute to the definition and the implementation of EDC or paper case record form of clinical studies.

– Be in contact with the global authorities.

– Leverage EDC development outsourced to external partners and manage related activities including setting up of data transfer agreements and appropriate clinical database reconciliation with internal database (ie safety database)

– Act as EDC representative

– Setup and lead clinical trial data and EDC specifications, EDC design, edit checks programming

– Maintain current awareness of regulations, guidance documents (Data Management Plan, Data Validation Plan…), advisory committees, industry standards, appropriate archiving, GCP and interna SOPs.

– Manage user access to the clinical database. Ensure appropriate training is received.

– Work closely with clinical project manager to ensure quality of clinical data throughout the clinical study lifecycle to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review or final database lock.

– Participate in the development and maintenance of Data management SOPs.

 

Your Profile :

– Minimum B.Sc. degree in Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science ;

– Minimum of 4 years of experience in clinical data management.

– Strong knowledge of CDISC standards is required ;

– Experience in biostatistics and/or SAS programming is a plus ;

– Strong critical thinking and problem solving skills ;

– Able to rapidly adapt to changing environment and circumstances ;

– Fluent in English and French.

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