Author: Noemie Oliva

Senior Medical Expert Healthcare/OTC

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

 

Due to this growth my client is looking for a Senior Medical Expert with strong experience in OTC drug products to join their in Lausanne area.

 

Responsibilities

  • Promote science based innovative projects and contribute to development and implementation of new scientific concept
  • Contribute to and support development of Cosmetics, Medical Devices OTC products
  • Deliver medical expertise as requested
  • Expert contribution in due diligence as needed
  • Responsible for the validation of the medical content of Idea Briefs
  • Accountable for medical/scientific relevance of claim support strategy
  • Contribute to the development of the clinical plan upon request and in case of complex and/or innovative projects
  • Contribute to and Support development of Medical Devices and OTC products
  • Accountable for providing effective CDP for OTC products and Medical Devices
  • Responsible for the clinical sections of regulatory documents
  • Review and contribute to dossier submission documents in collaboration with internal stake holders
  • Ensure that internal SOPs, processes are followed
  • Propose/implement any measures susceptible to improve clinical and innovation development processes and strategies
  • Responsible for providing internal training on skin conditions to the Clinical Operations Team and the overall healthcare team
  • Review and validate the medical content of internal publications
  • Contribute to Due Diligence evaluation and provide Medical Expertise as needed

 

Profile:

  • Medical Doctor
  • 10 years minimum of experience of clinical development / research in pharmaceutical and/or cosmetic industry or CRO
  • Experience in Dermatology, development of OTC products mandatory. Medical Device Development knowledge is a plus
  • Strong communication skills; Expert level oral and written English
  • Results orientated with a hands-on, can-do attitude

Please send application to noliva@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 CVs to noliva@axepta.com 

Biossample Coordinator

My client is an innovating, dynamic and niche international biopharma company currently expanding their clinical team.

Due to this growth my client is looking for a Biosample Coordinator join them in Lausanne area to manage the operations and logistics necessary to execute the testing, analysis, and storage of biological samples for clinical trials and translational projects in compliance with relevant regulations.

 

Responsibilities:

 

  • Work in matrix organization in close collaboration with the Clinical Operations team and Translational Medicine functions to manage sample tracking, receiving, and storage processes for clinical and translational projects.
  • Support clinical study activities in the preparation and review of study-related documents (such as ICF, CRF, laboratory manual, DTS, etc.).
  • Interface with laboratory personnel, sample processing vendors, and other vendors as needed to ensure proper shipment of samples, respond to issues as needed, and to ensure study objectives are met.
  • May contribute to the assessment of site and lab feasibility for biological sample collection, handling and storage.
  • Be responsible for the development and maintenance of a biorepository database for human and non-human biological samples.
  • Ensure biosample process consistency across clinical studies within their respective projects and manage sample logistics from patient to data, in compliance with GXPs.
  • Participates in process improvement projects (SOPs, work instructions, training materials) in collaboration with QA and clinical study teams.
  • Forecasts the biosample operational costs and review contracts and invoices.

 

Your profile:

  • Degree in life sciences
  • Strong knowledge and good understanding of clinical trials and translational medicine in biomedical research.
  • Minimum of 3 years proven experience working in teams managing clinical studies.
  • Proven experience working with clinical biosample logistics and operations.
  • Knowledge of GCP, GCLP and ICH guidelines, and animal welfare regulations (training can be done after recruitment).
  • Excellent IT and analytical skills. Experience with sample management systems and procedures is a plus.
  • Fluent in English

Please send your application 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 

Senior HCP 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

Senior Global Project Manager- Biologics

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 Senior Project Manager to provide day-to-day project management leadership to global drug development project teams in the innovation and pharmaceutical strategy group.

Responsibilities:

  • Work closely with the Head Project Management and Global Program Leaders to establish and maintain project plans and budgets, organize and lead project team meetings, foster communication and coordinate between functional groups, ensuring adequate resourcing to meet goals, identifying risks and mitigations and providing updates on project status to project team leaders to ensure the timely supply of quality products to their patients.
  • Create and maintain integrated product development plans that reflect core objectives, minimize risk, and deliver results.
  • Manage global, cross-functional, complex drug development project teams/sub-teams and provides advanced project management support, including action item tracking, organization and communication of materials
  • Organise interdepartmental activities to ensure completion of assigned projects within scope, on schedule and within budget constraints
  • Identify, monitor, and analyse business project risks and prepares project planning contingency scenarios.
  • Ensure accurate tracking and reporting of project milestones and deliverables
  • Prepare project updates for governance meetings and clearly communicates status in written documents and presentations
  • Ensure documentation of, and access to, key project documents, presentations and data
  • Assume full responsibility for managing specific aspects of the project as designated by team leadership.

Your profile:

 

  • BA/BS is required; advanced degree (MBA) is a plus
  • Minimum 10 years of relevant experience in experience in a Biopharma or Biotech environment with at least 7 years of experience in Project Management
  • Self-directed, process oriented and able to work well in a team environment
  • Thorough understanding of the drug development processes
  • Hands-on expertise with project management tools (e.g. Planisware)
  • Good understanding of financial and resource planning systems and processes and ability to coordinate project level budget/resource estimates and manage actuals vs. plan
  • PMP certification would be an advantage
  • Fluent in English is a must

 

Please find send your application to noliva@axepta.com

VP of Clinical Services

My client, a growing mid-size pharmaceutical services company is currently growing their activities therefore looking for a VP of Clinical Services to join one of their office in Ulm Area, Germany and manage full service Clinical CRO division.

 

Responsibilities:

 

  • Responsible for all operational and strategic aspects of the design and implementation of clinical trial services, overall client satisfaction and divisional profitability
  • Supervise and develop 6 Departmental Heads to assure high quality Service delivery.
  • Leading, guiding and inspiring approx. 80 employees, through your Clinical Services

team (Clinical Conduct and Medical Services in our Phase I CPU, Clinical Laboratory,

Project Management, Data Management, Biostatistics, Medical Writing,

Regulatory Affairs and Monitoring Services)

  • Supervise ongoing projects and assure their performance with respect to quality

standards (SOPs, ICH-GCP), contract and timelines

  • Responsible for the divisional P&L, with oversight of the clinical program budget

across the portfolio

  • Providing active support and participation in client acquisition and contracting in

close collaboration with Business Development and the other divisional leaders.

  • Assure a continuous communication between the project team and client for an

effective study performance, respecting administrative and regulatory authority matters, ensuring client satisfaction

  • Further development and improvement of the divisional organization including

structure, processes and systems with the objective of process efficiency, quality

enhancement and margin optimization

  • Fostering an environment supporting innovation and smart risk-taking in Clinical

Services to help the division continuously evolve and improve.

 

Your profile:

 

  • PhD or equivalent in Life Sciences (medicine or healthcare discipline preferred)
  • 15+ years of experience in Clinical Development, particularly in Early Development,

preferably in both Pharma and CRO, with at least 10 years of project and/or line

management experience in a Clinical CRO

  • Knowledge and experience in planning, conducting and reporting of clinical trials,

including practical experiences in Project Management, Clinical Operations and at

least a solid understanding of Data Management, Biostatistics and Pharmacovigilance.

  • Experience of leading a large operational team and effecting change
  • Strong financial acumen with a solid understanding of proposal and contract generation, operational and margin growth and budget management
  • Proven track record of succeeded business growth
  • Leadership and hands-on management, influencing skills, high personal initiative

and team spirit, commitment, and accountability

  • Distinct organizational, problem-solving and analytical skills
  • Excellent English skills oral and written, and at least a basic understanding of German.

 

Director Clinical Research Scientist Immuno-Oncology

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

Due to this growth, my client is looking for a Director Clinical Research Scientist to work with the physicians and other members of the Clinical Team to provide clinical research support for programs in Immuno-Oncology.

 

Responsibilities :

 

  • Development of protocols for clinical studies
  • Preparation of clinical development plans
  • Drafting of clinical scientific documents such as IND, IND amendments Investigator Brochures, Annual Reports and other FDA submissions
  • Monitor, review and summarize safety and efficacy data in ongoing studies
  • Assist with study design for exploratory development
  • Will lead the clinical matrix teams for assigned compounds
  • Develop relationships with appropriate consultants
  • Write abstracts and present data at scientific meetings, both internally and externally
  • Serve as liaison to project teams, CRO’s and others

 

Your profile:

 

  • Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred
  • Minimum of 4 to 6 years of experience in research with at least 3 or more years of drug development experience are preferred
  • Prior Immuno-Oncology/ Oncology Drug Development experience
  • Ability to multi-task and work in a fast-paced environment
  • Excellent written and oral communication skills
  • Strong Analytical ability
  • Oral and Written proficiency in English

Please send your application to noliva@axepta.com 

Global Brand Director Immuno-Inflammation

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

Due to this growth my client is looking for a Global Brand Director to join their strategic marketing department in Immunology and Inflammation and to be responsible for the development and implementation of the global marketing strategy and execution for current and future pipeline products.

 

 

Responsibilities:

 

  • Working very closely with the Franchise head and the Global Franchise Team
  • Develop and refine the global marketing strategy, based on strong product value propositions addressed to key stakeholders to ensure successful commercialization
  • Prepare product positioning, patient and prescriber segmentation and key marketing messages
  • Together with the Global Franchise team, develop communication strategies to support value messages.
  • Work very closely with the global pricing and market access teams to define successful access strategies in key markets
  • Work closely with the key affiliates to understand the market requirements and prepare global solutions that can be implemented at local level.
  • Prepare the pre-launch market
  • Assess the field force requirements and ensure launch readiness for successful launch of biologics
  • Develop all aspects of product branding
  • Prepare logistics aspects (packaging, production planning …)
  • Prepare all launch media (campaign, PR, digital …).
  • Coordination of all scientific and medical communications of brands / products.
  • Pricing guidelines and market access data in collaboration with the market access and regional marketing team
  • Leading the congress activities from marketing perspective (booth, messaging, visuals etc)
  • Coordinates the marketing advisory board meetings
  • KOL development (national and regional)
  • Monitoring the financial performance of brands / products.

 

Your profile:

 

  • Ideally double science training (engineer, pharmacy or medicine) and degree Business School.
  • At least 7-10 years of global marketing experience in a pharmaceutical prescription industry
  • Experience working on Chronic Diseases
  • Deep understanding on the requirements of global commercialization of biologic products, ideally with experience in dermatology
  • MUST have experience launching products in the US and key European markets
  • Experience in global transversal projects
  • Good written and oral communication skills in English

Please send your profiles to noliva@axepta.com  

Regulatory Affairs Publishing and eCTD specialist

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

 

Due to this growth my client is looking for a Regulatory 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

 

 

 

Electronic Document Management System Manager (EDMS)

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 an Electronic Document Management System Manager to join them on a permanent contract.

 

Responsibilities:

 

• Responsible of the Global Regulatory EDMS (Electronic Document Management System)
• Manage Regulatory requirements and define business processes
• Coordinate with IT support and/or service providers as needed

• Responsible to maintain Global Regulatory EDMS in a compliant and validated state
• Maintain/develop the application and related processes
• Ensures maintenance and business support of the system
• Interface with key users from R&D departments (Regulatory, Clinical, Pre-Clinical …)
• Interface with IT for technical support
• Coordinate/Implement training program for end users
• Lead/Organize Computer System Validation (CSV) activities
• Lead User Teams and Governance Board
• Maintain SOPs, instructions related to EDMS.
• Propose/implement process improvements

• Propose/participate in steps required to maintain regulatory compliance

 

Your profile:

 

· Degree in IT or Scientific or equivalent

· Minimum 8 years experience in Pharmaceutical Industry

· Minimum 5 years in similar role in IT, Clinical or Regulatory departments

· Strong experience with EDMS (Documentum/D2 preferred)

· Experience with Computer system validation (CSV)

 

 

Regulatory Information Management System Manager

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

 

Due to this growth my client is looking for a Regulatory Information Management System Manager to join them on a permanent contract.

 

Responsabilities :

  • Manage RIMS application in compliance with regulatory requirements.
  • Managing the Regulatory Information Management System (RIMS) for all products
  • Maintaining optimal interface with Global and Local Regulatory Affairs team members
  • Coordinating with IT support and external service providers
  • Interface with Coordinators to support function for all products.
  • Propose/animate/manage evolution of application to improve efficiency and to ensure continued regulatory compliance.
  • Manage training support for new users.
  • Monitor data entry compliance.
  • Propose/manage corrective action plans, if necessary.
  • Write SOPs, forms, etc. to describe the day-to-day operations of function.
  • Propose/implement process improvements
  • Monitor internal and Professional communications  concerning relevent regulations (ICH, FDA, EMA …)
  • Propose/participate in steps required to maintain regulatory compliance

 

Your profile :

  • BSc, MSc in scientific, IT or administrative discipline or equivalent experience
  • 5 years experience Pharmaceutical Industry
  • 3-5 years in similar role
  • Experience of managing service providers.
  • Regulatory affairs processes and EU registration procedures
  • Regulatory Information Management systems (Register™ preferred)
  • Computer System Validation (CSV)
  • Fluent in English

 

Senior Global Marketing Manager HCP-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 Marketing Manager with good experience with Healthcare products 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

VP of Clinical Services Germany

My client, a growing mid-size pharmaceutical services company is currently growing their activities therefore looking for a VP of Clinical Services to join one of their office in Ulm Area, Germany and manage full service Clinical CRO division.

Responsibilities:

 

  • Responsible for all operational and strategic aspects of the design and implementation of clinical trial services, overall client satisfaction and divisional profitability
  • Supervise and develop 6 Departmental Heads to assure high quality Service delivery.
  • Leading, guiding and inspiring approx. 80 employees, through your Clinical Services
  • team (Clinical Conduct and Medical Services in our Phase I CPU, Clinical Laboratory,
  • Project Management, Data Management, Biostatistics, Medical Writing,
  • Regulatory Affairs and Monitoring Services)
  • Supervise ongoing projects and assure their performance with respect to quality
  • standards (SOPs, ICH-GCP), contract and timelines
  • Responsible for the divisional P&L, with oversight of the clinical program budget
  • across the portfolio
  • Providing active support and participation in client acquisition and contracting in
  • close collaboration with Business Development and the other divisional leaders.
  • Assure a continuous communication between the project team and client for an
  • effective study performance, respecting administrative and regulatory authority matters, ensuring client satisfaction
  • Further development and improvement of the divisional organization including
  • structure, processes and systems with the objective of process efficiency, quality
  • enhancement and margin optimization
  • Fostering an environment supporting innovation and smart risk-taking in Clinical
  • Services to help the division continuously evolve and improve.

 

Your profile:

 

  • PhD or equivalent in Life Sciences (medicine or healthcare discipline preferred)
  • 15+ years of experience in Clinical Development, particularly in Early Development,
  • preferably in both Pharma and CRO, with at least 10 years of project and/or line
  • management experience in a Clinical CRO
  • Knowledge and experience in planning, conducting and reporting of clinical trials,
  • including practical experiences in Project Management, Clinical Operations and at
  • least a solid understanding of Data Management, Biostatistics and Pharmacovigilance.
  • Experience of leading a large operational team and effecting change
  • Strong financial acumen with a solid understanding of proposal and contract generation, operational and margin growth and budget management
  • Proven track record of succeeded business growth
  • Leadership and hands-on management, influencing skills, high personal initiative
  • and team spirit, commitment, and accountability
  • Distinct organizational, problem-solving and analytical skills
  • Excellent English skills oral and written, and at least a basic understanding of German.

 

Please send your appliation to noliva@axepta.com