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12 month contractor role - Manager, Medical Information Operations Stockley Park Job Responsibilities The Manager, Medical Information Operations will be responsible for ensuring appropriate oversight and quality assurance of outsourced medical information activities to support remdesivir/Covid-19 for the ACE (Australia, Canada, Europe) region.This will involve coordinating with global medical information colleagues to ensure availability/dissemination of response documents and providing responses for use by the vendor to respond to requests from HCPs/patients.Training of vendor staff on remdesivir/Covid-19 and medical information resources. Working with the Senior Manager, Medical Information Operations to ensure operational excellence within the Medical Information function across the ACE region. Routine responsibilities will include:Managing the relationship between company and outsourced medical information vendors, including with affiliate medical information/medical affairs and other functions. Ensuring the outsourced medical information vendor has access to the appropriate information that they need to provide excellent customer service to support requests relating to remdesivir/Covid-19. Ensuring appropriate oversight of the performance of outsourced medical information vendors, including training of vendor staff, and the implementation of processes that ensure that the vendor service meets expected standards. Updating and ensuring compliance with Medical Information working practices and operating procedures. Working closely with affiliates and vendors to ensure inspection readiness, including responses to findings and implementation of process improvements. Implementing the quality management plan for key Medical Information activities across the ACE region. Knowledge/SkillsAble to work under limited direction. Highly self-motivated and able to perform multiple tasks in a timely fashion. Excellent interpersonal, and verbal and written communication skills and ability to navigate through ambiguity. Demonstrated success in developing and maintaining good working relationships with internal colleagues and external contacts and influence cross-functionally at various levels. Ability to manage and lead multiple projects and change management initiatives in a fast-paced, cross-functional environment. Knowledge of applicable country/regional regulations and legal requirements for the provision of medical information services, and for adverse event and product quality complaint reporting, in the pharmaceutical environment. Specific Education and Experience Requirements Typically requires a Pharmacy or life sciences degree plus at least four years' experience in Medical Information in the pharmaceutical industry Experience of working with medical information vendors is preferred. Previous Medical Information experience at a regional level in the pharmaceutical industry is strongly preferred. Parkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.
TÉCNICO DE ESTUDIOS DEL CONSUMIDOR / CUSTOMER INSIGHT - Sector Cosmética
Working for a global organisation you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. I am looking for two experienced HR Shared Service professionals who want to take on new challenges and work for a business where you can bring your own ideas to help improve and streamline processes and procedures.Specific Job Requirements- First point of contact for HR, Managers and Employees within EMEA on a wide range of Employee Relations issues including performance management, grievances and disciplinary issues - Provides specific advice and guidance both verbally and in writing on the effective management of ER issues to aid resolution - Under direction, conducts fact finding or handles investigations or parts of the investigation process to gather appropriate information from a variety of sources to enable recommendations to be made on ER issues - Provide support in developing policies within Europe. Use the ER case management system to log and track case progress - Manipulates Excel spreadsheets into different sorts and formats and works with Word, Power Point documents as directed by immediate manager. - Gathers, collects, records, tracks and verifies relatively complex data and information from multiple sources. - Liaises with external agencies or organizations to coordinate activities which are important to the function of the department.Knowledge- Good verbal, written, and interpersonal skills are required. - Working knowledge of ER processes, approaches and best practice in the UK. Experience in Europe is desirable - Proactive approach with excellent consultative, coaching, counselling and conflict resolution skills - Intermediate to Advanced knowledge and experience using a number of office software such as Excel, PowerPoint, Word, Access, etc. - Requires knowledge and understanding of administrative and office policies and procedures. - Typically works under limited supervision and may receive general direction on new lines of work or special assignments.Specific Education and Experience Requirements- Requires a minimum of a high school diploma plus 2 years HR administrative experience. Some experience of meeting and giving guidance to managers and others in HR on policies and processes - Experience of handling difficult and sometimes sensitives topics, able to deal with ambiguity and work through to gain clarity of issues Ideally CIPD qualified or working towards accreditation or equivalentParkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.
Clinical Program Manager - Late PhaseAn exciting opportunity has arisen to join our leading Bio-tech client in their Clinical Operations Late Phase team based in West London as a Clinical Program Manager to be responsible for the management of post-authorisation studies, investigator sponsored research and compassionate use programs across different therapeutic areas.Job Requirements Successfully manages all aspects of assigned post-authorisation studies within designated program budgets and timelines with primary focus on studies detailed in the product Risk Management Plan.Maintain current knowledge of both local & regional legislation regarding execution of post-authorisation studies.Responsible for development and monitoring of study budgets and timelines and managing adjustments as necessary.Actively lead Study Management Teams for assigned studies and provide strategic and operational advice as required.Actively participate in CRO study calls as appropriate.Conduct study feasibility in conjunction with internal Medical Affairs and Clinical Operations staff and/or external collaborators or CROs.Develops RFPs, select CROs/vendors, and manages external resources.Communicates project status and issues and ensure project team goals are met.Anticipates moderately complex obstacles and client difficulties and implements solutions to achieve project goals.Contributes to development of abstracts, presentations, and manuscripts.Co-monitoring may be required.Provide support to Investigator Sponsored Trials including Fair Market Value and feasibility assessment, contract milestone advice, tracking and publication follow-up as requiredIdentify any "best practice" opportunities to share across Therapeutics Areas and sites.Ensure local consistency & alignment with GSI global process & procedure, whilst providing regional perspective & expertise.Participate in the development of SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory and safety documents as required.With limited supervision may participate in or lead departmental strategic initiatives.Develop good working relationships with the Global Late Phase operational team and cross-functional staff internationally as required.Participate as an active member of the Global Clinical Operations Late Phase extended Leadership team and other team meetings.Serve as an ambassador for Clinical Operations internally and externally.Provide training to colleagues on process changes/improvements as necessary.Recruit, hire, mentor, and manage direct reports as required and support their professional development.Occasional travel is required.Knowledge, Experience And Skills BSc Life Sciences. A MSc or PhD would be advantageous (or international equivalent).Relevant clinical experience in the pharmaceutical industry.Experience in managing staff as well as mentoring and developing junior staff.Experience in clinical study management including the delivery of Phase IV and non-interventional studies is essential.Experience in the review and oversight of Investigator Sponsored Research.Knowledge of post-marketing requirements and different types of Drug Utilisation Studies and Post Authorisation Safety and Efficacy Studies.Experience in the provision of compassionate use would be beneficial.Knowledge of regulatory affairs and drug safety.Experience in developing RFPs and selection and management of CROs/vendors.Ability to write study protocols, plans, study reports and regulatory documents (e.g. IND, DNA, etc.) with little supervision.Excellent interpersonal skills, and demonstrated ability to lead is required.Strong communication and influence skills and ability to create a clear sense of direction is necessary.Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.Extensive knowledge of ICH GCP, FDA, EMEA regulations & guidelines.Knowledge of drug development & commercialisation processes.Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.Parkside Recruitment Ltd is acting as an Employment Agency in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.
Our client is a bio-pharmaceutical company with therapeutic in HIV/AIDS, liver diseases, cancer and inflammation.They are looking for an Associate Director to deliver strategic branded and unbranded communication programs and patient advocacy engagement as it enters rheumatology. The role reports in to the US and works closely with cross-functional and Public Affairs colleagues at the global and country levels.Job duties include:Setting the communications strategy for markets outside of the US.Shaping the product launch communications and advocacy engagement plans.Working in partnership to drive alignment across company communicationsCommunicating data and regulatory milestonesDesigning and implementing disease awarenessDeveloping compelling materials to support external communications, including key messages, Q&A documents, press releases, presentations, videos, social media content, etc.Responding to media requests and coordinating interviews with spokespeople and opinion leader spokespeople, as appropriateDeveloping/strengthening relationships with a wide variety of community advocates, media and other influential organisationsContinuously scanning the environments to proactively identify and manage issuesCoordinating with cross-functional colleagues to ensure alignment and collaboration in strategic priorities and messaging across different stakeholdersManaging agency partners Knowledge, Experience and SkillsGlobal or pan-EU experience in product PR, media and advocacy within the pharmaceutical sectorDemonstrated experience in media relations (traditional and social), issues management; knowledge of healthcare and industry media and reporting trendsExperience of working within the inflammation therapy area is highly desired but not essentialExperience managing multiple projects (timelines, budgets, priorities) simultaneously; flexibility and results-oriented focus are essentialAbility to interact with senior management and high-profile experts appropriately, with confidence and easeAbility to understand and accurately communicate complex scienceAbility to give formal presentations to internal and external audiences of various sizesExperience working successfully with patient organisationsParkside Recruitment Ltd is acting as an Employment Agency in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.
Unser Kunde ist ein internationales Unternehmen aus dem Bereich Luxus-Kosmetik & Wellness. Das Unternehmen betreibt über 730 Filialen mit ca. 6.250 Mitarbeiter. Das Einzelhandelskonzept liegt sehr im Trend, schafft eine einzigartige Einkaufsatmosphäre und gehört zu einen der am stärksten wachsenden Lifestyle Unternehmen. Aktuell suchen wir für den Standort München nach einem Assistent Shop Manager München (m/w/d) – Kosmetik & Wellness
Unser Kunde ist ein internationales Unternehmen aus dem Bereich Luxus-Kosmetik & Wellness. Das Unternehmen betreibt über 730 Filialen mit ca. 6.250 Mitarbeiter. Das Einzelhandelskonzept liegt sehr im Trend, schafft eine einzigartige Einkaufsatmosphäre und gehört zu einen der am stärksten wachsenden Lifestyle Unternehmen.Aktuell suchen wir für den Standort Regensburg nach einem Assistent Shop Manager Regensburg (m/w/d) – Kosmetik & Wellness