Regional Submission Lead

hace 1 semana

Madrid, Madrid, España Merck Sharp & Dohme (MSD) A tiempo completo

Job DescriptionRegional Submission Lead Location:

Applicant can be located in any of the EEA (European Economic Area) countriesEMEA office or Home Based depending on location Main responsibilities:Accountable for overall management and coordination of the submission activities across EU countries for assigned Clinical Trials (Phase - Phase 4) spanning all therapeutic areas.

Accountable for the execution of the regional Clinical Trials Application (CTA) submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.

Facilitate the CTA submission by local personnel in a given country in compliance with ICH/GCP and country requirements, our company's policies and procedures, quality standards, and AE reporting requirements internally and externally.


Further responsibilities include, but are not limited to:

  • Acts in a cross-functional team that will facilitate the compilation and production of Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.).
  • Provide support for Drug Release Process in relation to EU-CTR (European Clinical Trial Regulation)
  • Where Clinical Research Organizations are contracted responsible for overseeing CRO activities, as required
  • Works independently to achieve team goals with high level of autonomy.
  • Role is accountable for performance metrics within role accountabilities
  • Identifies and proactively responds to issues, problems, or opportunities. Independently identifies the need for and collects information (from CTA working groups, HA-interactions etc.), to better understand and resolve issues & challenges.
  • Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions. Shares protocol-specific information and best practices across Extent of Travel Ability to travel domestically and internationally approximately up to 10% of working time.

Core competency expectations:

  • Knowledge in Project Management.
  • Strong organizational skills with demonstrated success required.
  • Excellent understanding of Drug Development; understanding of the Clinical Trial Submission process
  • Strong scientific and clinical research knowledge and experience is required for this position.
  • Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
  • Ability to collaborate with different stakeholders within GCTO and MRL in a matrix organization.
  • Strong Communication skills requiring proficiency in written and spoken English. The incumbent must be competent and effective in written and verbal communication.
  • Strategic thinking
  • The position requires extensive understanding of international cultural diversity in remote and virtual environment

Experience Requirements:

  • 4-6 years of relevant experience in clinical research
  • 2 years' experience in regulatory submission in the European Union is an advantage

Educational Experience:

  • Bachelor degree in Science (or comparable)
  • Advanced degree, (e.g., Master degree, MD, PhD)Who we are ...We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...Imagine getting up in the morning for a job as important as helping to save and improve lives around the world.

Here, you have that opportunity.

You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.

Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.

All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.

No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.

Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

RegularRelocation:

No relocationVISA Sponsorship:
Travel Requirements:10%

Flexible Work Arrangements:

Shift:

Valid Driving License:
Hazardous Material(s):SummaryLocation: ESP - Madrid - Madrid (Josefa Valcarcel); BEL - Brussels Capital Region - Brussels; BGR - Sofia City - Sofia (Nikola); AUT - Austria - Austria; ITA - Lazio - Roma; CZE - Central Bohemian - Prague (IT Riverview); CYP - Nicosia - Nicosia; DEU - Bayern - HaarType: Full time

  • EU Clinical Trial Submission Coordinator

    hace 3 semanas

    Madrid, Madrid, España J&J Family of Companies A tiempo completo

    EU Clinical Trial Submission Coordinator WDescriptionJohnson & Johnson is currently seeking a EU Clinical Trial Submission Coordinator to join our team located in Madrid, Leiden, Prague or Warsaw.About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex...

  • EU Clinical Trial Submission Coordinator

    hace 1 mes

    Madrid, Madrid, España J&J Family of Companies A tiempo completo

    EU Clinical Trial Submission Coordinator WDescriptionJohnson & Johnson is currently seeking a EU Clinical Trial Submission Coordinator to join our team located in Madrid, Leiden, Prague or Warsaw.About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex...

  • Regional Sales Lead, Inbound Solutions

    hace 1 semana

    Madrid, Madrid, España Chep A tiempo completo

    Regional Sales Lead, Inbound Solutions Southern Europe page is loaded Regional Sales Lead, Inbound SolutionsSouthern Europe Apply remote type Hybrid Remote locations Madrid, Spain time type Full time posted on Posted 30+ Days Ago job requisition id JR13434 CHEP helps move more goods to more people, in more places than any other organization on earth via our...

  • Regional Procurement Lead

    hace 1 semana

    Madrid, Madrid, España International Flavors & Fragrances A tiempo completo

    It's an exciting time to be part of the IFF family. We are a global leader in taste, scent and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy.This role could work 100% remotely, ideally coming to the site once a week.Being part of the renewed IFF EU procurement team, the Regional Procurement Lead...

  • Ed&cp Regional Site Strategy Lead

    hace 1 semana

    Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Position Summary:The Early Development and Clinical Pharmacology (ED&CP) Regional Site Strategy Lead (SSL) is accountable for the strategy to build and leverage investigator site capabilities and capacity for ED&CP trials in designated area / countries. This role will support program and study level country / site recommendations during feasibility and...

  • Regional Tax Lead

    hace 1 semana

    Madrid, Madrid, España dLocal A tiempo completo

    What's the opportunity? We are looking for a Regional Tax Lead based in Spain to join our Tax Team, who will be responsible for managing the Tax Compliance, Transfer Pricing, and Planning of the dLocal Group in Europe, the Middle East, and Africa._What will I be doing?: Deal with the incharge tax bureau for routine tax issues. Support business growth in...

  • Courier HR Operations Regional Lead

    hace 1 semana

    Madrid, Madrid, España Just eat Takeaway A tiempo completo

    As a Courier HR Operations Regional Lead you will lead five market-based teams of Courier HR Operations on a mission to ensure that the courier workforce is supported in the best way.You will lead five teams during an exciting time for our company and you will have the opportunity to shape a global division fit for Italy, Spain, Israel, Poland and Bulgaria....

  • Regional Product Market Lead

    hace 1 semana

    Madrid, Madrid, España Western Union A tiempo completo

    Western Union Madrid, SpainPosted 16 hours ago Permanent CompetitiveRegional Product Market LeadAre you results -oriented professional who enjoys playing a pivotal role in supporting successful product launches and commercialization? Are you seeking an opportunity where you can make significant impact by driving product development? Are you motivated to t...

  • Regional Market Access

    hace 1 semana

    Madrid, Madrid, España Sobi A tiempo completo

    Company DescriptionSobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.Job...

  • Regional Sales Lead, Inbound Solutions

    hace 1 semana

    Madrid, Madrid, España Brambles A tiempo completo

    Regional Sales Lead, Inbound Solutions - Southern Europe page is loaded Regional Sales Lead, Inbound Solutions - Southern Europe Apply remote type Hybrid Remote locations Madrid, Spain time type Full time posted on Posted 30+ Days Ago job requisition id JR13434 CHEP helps move more goods to more people, in more places than any other organization on earth via...

  • Senior Regional Quality Engineering Lead

    hace 1 semana

    Madrid, Madrid, España Amdocs A tiempo completo

    Job ID: Required Travel :Minimal Managerial - Yes Location: :Spain- Madrid (Customer Site)Who are we? Amdocs helps those who build the future to make it amazing. With our market-leading portfolio of software products and services, we unlock our customers' innovative potential, empowering them to provide next-generation communication and media experiences for...

  • Senior Regional Quality Engineering Lead

    hace 1 semana

    Madrid, Madrid, España Amdocs A tiempo completo

    Job ID: 183999Required Travel : MinimalManagerial - YesLocation: :Spain- Madrid (Customer Site)Who are we? Amdocs helps those who build the future to make it amazing. With our market-leading portfolio of software products and services, we unlock our customers' innovative potential, empowering them to provide next-generation communication and media...

  • Senior Regional Quality Engineering Lead

    hace 12 horas

    Madrid, Madrid, España Amdocs A tiempo completo

    Job ID:Required Travel: Minimal Managerial - Yes Location::Spain- Madrid (Customer Site) Who are we? Amdocs helps those who build the future to make it amazing. With our market-leading portfolio of software products and services, we unlock our customers' innovative potential, empowering them to provide next-generation communication and media experiences for...

  • Regional Site Strategy Lead Gco Ed&Cp Oncology

    hace 1 semana

    Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Job Description - Regional Site Strategy Lead GCO ED&CP Oncology W) Regional Site Strategy Lead GCO ED&CP Oncology W Description Position Summary: The Early Development and Clinical Pharmacology (ED&CP) Regional Site Strategy Lead (SSL) is accountable for the strategy to build and leverage investigator site capabilities and capacity for ED&CP trials in...

  • Regional Marketing Lead

    hace 1 semana

    Madrid, Madrid, España Personio A tiempo completo

    The Role:We are Marketing. As a team, we actively drive Personio's growth by generating demand and generating leads. Our roster of marketeers strategise, conceptualise, create, craft, review, iterate and manage the journey from curious to customer. You're going to fit right in if you're ready to take on the challenges and problems of our target group, and...

  • Lead Regional Tax

    hace 1 semana

    Madrid, Madrid, España Sandoz A tiempo completo

    2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, it's growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers...

  • Director, Regional Regulatory Strategy, Infectious

    hace 1 semana

    Madrid, Madrid, España Moderna A tiempo completo

    The Role:Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide,...

  • Regional Site Strategy Lead Gco Ed&cp Oncology

    hace 1 semana

    Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Position Summary:The Early Development and Clinical Pharmacology (ED&CP) Regional Site Strategy Lead (SSL) is accountable for the strategy to build and leverage investigator site capabilities and capacity for ED&CP trials in designated area / countries. This role will support program and study level country / site recommendations during feasibility and...

  • Senior Regional Quality Engineering Lead

    hace 1 semana

    Madrid Centro, Madrid, España Amdocs A tiempo completo

    Job ID: 183999Required Travel :MinimalManagerial - YesLocation: :Spain- Madrid (Customer Site)Who are we? Amdocs helps those who build the future to make it amazing. With our market-leading portfolio of software products and services, we unlock our customers' innovative potential, empowering them to provide next-generation communication and media experiences...

  • Regional Launch Manager, Sandoz International Region

    hace 1 semana

    Madrid, Madrid, España Sandoz Farmacéutica, S.A. A tiempo completo

    Today Sandoz is a global market leader in Generics and Biosimilar medicine. With forecasts indicating at least adoubling of the global Biosimilar market in the decade ahead, Sandoz is well positioned to become the leader inthe market expansion driven by those who will join our team over the coming months.The role of the Regional Launch Manager, Region...