![Thermo Fisher Scientific](https://media.trabajo.org/img/noimg.jpg)
Country Approval Specialist
il y a 4 semaines
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Summarized Purpose:
Participates in the management and preparation, review and coordination of Country Submissions in line with global submission strategy.
Key responsibilities
Prepares, reviews and coordinates, under guidance, local regulatory submissions MoH, EC, additional special national local applications if applicable, gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. Provides, under mentorship local regulatory strategy advice (MoH &/or EC) to internal clients. Provides project specific local SIA services and coordination of these projects. May have contact with investigators for submission related activities. Key-contact at country level for either Ethical or Regulatory submission-related activities. Coordinates, under mentorship, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation. Achieves PPD’s target cycle times for site. May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. May develop country specific Patient Information Sheet/Informed Consent form documents. May assist with grant budgets(s) and payment schedules negotiations with sites. Supports the coordination of feasibility activities, as required, in accordance with agreed timelines. Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner. Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Keys to Success
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
Knowledge, Skills and Abilities:
Effective oral and written communication skills Excellent interpersonal skills Strong attention to detail and quality of documentation Good negotiation skills Good digital literacy and the ability to learn appropriate software Good English language and grammar skills Basic medical/therapeutic area and medical terminology knowledge Ability to work in a team environment or independently, under direction, as required Basic organizational and planning skills Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
-
Country Approval Specialist
il y a 2 semaines
Ivry-sur-Seine, Île-de-France ThermoFisher Scientific Temps pleinJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step...
-
Country Approval Specialist
il y a 3 semaines
Ivry-sur-Seine, Île-de-France ThermoFisher Scientific Temps pleinJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step...
-
Country Approval Specialist
il y a 5 jours
Ivry-sur-Seine, France Thermo Fisher Scientific Temps pleinAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Country Approval Specialist
il y a 4 jours
Ivry-sur-Seine, France Thermo Fisher Scientific Temps pleinAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Ivry-sur-Seine, France La Relève Temps pleinWij zijn op zoek naar een Web Country Manager Nederland / Sport Specialist voor een van onze klanten, in het kader van hun groei. BedrijfsbeschrijvingSluit je aan bij onze klant, een van de Europese leiders op het gebied van online sportinformatie die een volledig aanbod van digitale media voor sportfans biedt.Onze klant biedt zijn gebruikers een reeks...
-
Sales Specialist Regenerative portfolio
il y a 4 semaines
Ivry-sur-Seine, France Nobel Biocare France SAS Temps pleinDescription : Responsible for growth and expansion of direct sales and profit margins within assigned accounts and/or territory/region on products or services. Establishes professional relationships with key personnel in customer accounts. Meets assigned targets for profitable sales volume and margin dollars. Available to travel (Rep co-travelling,...
-
Sales Specialist Regenerative portfolio
il y a 2 semaines
Ivry-sur-Seine, France Nobel Biocare France SAS Temps pleinDescription : Responsible for growth and expansion of direct sales and profit margins within assigned accounts and/or territory/region on products or services. Establishes professional relationships with key personnel in customer accounts. Meets assigned targets for profitable sales volume and margin dollars. Available to travel (Rep co-travelling,...
-
CDI - Web Country Manager Nederland / Sport Specialist (Sport) (F/H)
il y a 2 semaines
Neuilly-sur-Seine, France La Relève Temps pleinWij zijn op zoek naar een Web Country Manager Nederland / Sport Specialist voor een van onze klanten, in het kader van hun groei. BedrijfsbeschrijvingSluit je aan bij onze klant, een van de Europese leiders op het gebied van online sportinformatie die een volledig aanbod van digitale media voor sportfans biedt.Onze klant biedt zijn gebruikers een reeks...
-
Senior Regulatory Affairs Specialist
il y a 1 jour
Ivry-sur-Seine, France Thermo Fisher Scientific Temps pleinAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Senior Director/Executive Director, Global Regulatory Affairs-EMEA
il y a 3 semaines
Neuilly-sur-Seine, France Lilly Temps pleinWe’re looking for people who are determined to make life better for people around the world. Purpose: The Senior Director/Executive Director, Global Regulatory Affairs (GRA)-EMEA or Regional Regulatory Scientist is accountable to establish the local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan aligns to the...
-
Senior Director/Executive Director, Global Regulatory Affairs-EMEA
il y a 2 semaines
Neuilly-sur-Seine, France Lilly Temps pleinWe’re looking for people who are determined to make life better for people around the world. Purpose: The Senior Director/Executive Director, Global Regulatory Affairs (GRA)-EMEA or Regional Regulatory Scientist is accountable to establish the local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan aligns to...
-
Regional Marketing Manager France and Benelux
il y a 4 semaines
Ivry-sur-Seine, France Nobel Biocare France SAS Temps pleinDescription : Main Tasks: Lead the Regional Marketing Organization. Implement the Global marketing strategy locally in the Region / countries and ensure the effective implementation of tactical marketing programs defined by Global Marketing, Global Product management, Global Launch management and Global / CEU T&E. Be part of the team of...
-
Regional Marketing Manager France and Benelux
il y a 2 semaines
Ivry-sur-Seine, France Nobel Biocare France SAS Temps pleinDescription : Main Tasks: Lead the Regional Marketing Organization. Implement the Global marketing strategy locally in the Region / countries and ensure the effective implementation of tactical marketing programs defined by Global Marketing, Global Product management, Global Launch management and Global / CEU T&E. Be part of the team of...
-
Cdd - Spécialiste Optimisation Catalogue Et
Il y a 2 mois
Neuilly-sur-Seine, France Sephora France Temps pleinCompany: Sephora France - Country / Region : France - City : NEUILLY SUR SEINE - Business group: Distribution Sélective - Contract type: CDD - Function: Digital - Reference No.: 229001 - Date of publication: 2023.05.24 POSITION CDD - Spécialiste Optimisation Catalogue et E-store (F/H) PROFILE Chez Sephora, nous sommes unis et défendons nos convictions...
-
Internal Sales Specialist Vmware
il y a 2 jours
Épinay-sur-Seine, France TD SYNNEX Temps pleinJob Purpose: Internal sales specialised within a sub BU allocated to accounts where possible, deep knowledge of portfolio, process and vendor pricing, manages all quotes and closes orders; incentivized based on part of the portfolioResponsibilities:Build Excellent customer and vendor sales relationships through proactive engagement and demonstrable...
-
Digital Marketing Specialist
il y a 1 mois
Villebon-sur-Yvette, France Videojet Temps plein**About Us** Videojet Technologies, Inc. is the global leader in the manufacturing of coding, printing and marking products. This high technology product prints variable information, such as expiration dates on grocery products, packaged goods, pharmaceuticals or catalogues. Our industry is pivotal in ensuring end users consume their food, beverage and...
-
Cdi - Catalog Specialist - Polish Fluent (F/H)
il y a 6 jours
Neuilly-sur-Seine, France RIMOWA GmbH Temps pleinCompany: Sephora France - Country / Region : France - City : NEUILLY SUR SEINE - Business group: Distribution Sélective - Contract type: CDI - Function: Digital - Reference No.: 223542 - Date of publication: 2023.06.12 POSITION CDI - Catalog Specialist - Polish fluent (F/H) PROFILE Chez Sephora, nous réimaginons la beauté, découvrons de nouvelles...
-
Graduate opportunity: Global Events Specialist
il y a 3 semaines
Neuilly-sur-Seine, Île-de-France Lenovo Temps pleinGraduate opportunity: Global Events SpecialistGeneral InformationReq #WD Career area:MarketingCountry/Region:FranceState:Hauts-de-SeineCity:Rueil-MalmaisonDate:Wednesday, May 22, 2024Working time:Full-timeAdditional Locations : Spain - Madrid - Madrid United Kingdom - Hampshire - Farnborough France - Hauts-de-Seine - Rueil-Malmaison Italy - Milano - San...
-
Graduate opportunity: Global Events Specialist
il y a 2 semaines
Neuilly-sur-Seine, Île-de-France Lenovo Temps pleinGraduate opportunity: Global Events SpecialistGeneral InformationReq #WD Career area:MarketingCountry/Region:FranceState:Hauts-de-SeineCity:Rueil-MalmaisonDate:Wednesday, May 22, 2024Working time:Full-timeAdditional Locations : Spain - Madrid - Madrid United Kingdom - Hampshire - Farnborough France - Hauts-de-Seine - Rueil-Malmaison Italy - Milano - San...
-
Commercial Sédentaire Spécialiste DELL- H/F – Alternance
il y a 2 semaines
Carrières-sur-Seine, France TD SYNNEX Temps pleinQui sommes-nous ?TD SYNNEX, leader mondial de la distribution IT. Présent dans 100 pays, nous adressons plus de 125 000 clients. Notre ambition, anticiper les évolutions permanentes de l'écosystème IT et devenir un orchestrateur de solutions.Nous nous soucions de nos partenaires, de nos collaborateurs, de nos investisseurs et du monde qui nous entoure....