Regulatory and Business Development Manager
6 days ago
Job Overview
As a key member of our team at IQVIA Argentina, you will be responsible for directing and managing the delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This includes pre-award activities, oversight of the scope of work, budget, and resources.
Key Responsibilities
- Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
- Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project-related issues where required.
- Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
- Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
- Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials, while enabling compliance with regulatory requirements.
- Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
- Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
- Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
- Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
- Execute operational strategy/expectations for maintenance of clinical study approvals, authorizations, and review/negotiation of contracts and essential documents.
- Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required.
- Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines, and project plans with project-specific information.
- May take a lead role in developing long-standing relationships with preferred IQVIA customers.
- Deliver presentations/training to clients, colleagues, and professional bodies, as required.
- May be involved in activities related to monthly study budget planning and reviews.
Requirements
- Bachelor's Degree in Life Sciences or related field required. 7 years' relevant experience in a scientific or clinical environment, including demonstrable experience in an international role. Equivalent combination of education, training, and experience.
- Strong negotiation and communication skills with ability to challenge.
- Excellent interpersonal skills and strong team player.
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects.
- Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process.
- Demonstrated proficiency in using systems and technology to achieve work objectives.
- Good regulatory and/or technical writing skills.
- Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines.
- Good leadership skills, with ability to motivate, coach, and mentor.
- Good organizational and planning skills.
- Ability to exercise independent judgment, taking calculated risks when making decisions.
- Good presentation skills.
- Proven ability to establish and maintain effective working relationships with co-workers, managers, and sponsors.
- Excellent understanding of study financial management.
- Proven ability to work on multiple projects balancing competing priorities.
-
Regulatory and Business Development Manager
3 days ago
Solna Municipality, Sweden IQVIA Full timeJob OverviewAs a key member of the IQVIA team, you will be responsible for directing and managing the delivery of all required site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This includes pre-award activities, oversight of the scope of work, budget, and resources.Key ResponsibilitiesOversee the...
-
International Trainee
1 week ago
Solna Municipality, Sweden Vattenfall Full timeAbout the JobWe are seeking a talented individual to join our team as an International Trainee in Strategy and Business Development. As a key member of our team, you will play a crucial role in shaping the path towards fossil-free living.About the TraineeshipThis traineeship offers a unique opportunity to kickstart your career in sustainable business. You...
-
Regulatory Affairs Specialist
17 hours ago
Solna Municipality, Sweden Kenvue Full timeRegulatory Affairs AssociateKenvue is seeking a highly skilled Regulatory Affairs Associate to join our team in Stockholm, Sweden.This role reports to the Regulatory Affairs Manager and is responsible for overseeing a range of regulatory activities for assigned medicines, medical devices, cosmetics, and/or food supplement consumer products within their...
-
Business Development Manager
5 days ago
Solna Municipality, Sweden TD Synnex Full timeAbout the Role:We are seeking a highly motivated and experienced Business Development Manager to join our team at TD SYNNEX. As a Business Development Manager, you will be responsible for identifying and pursuing new business opportunities, building and maintaining relationships with key stakeholders, and driving sales growth across our portfolio of IT...
-
Regulatory and Start Up Specialist 2
17 hours ago
Solna Municipality, Sweden IQVIA Full time{"Job OverviewAs a Regulatory and Start Up Specialist 2 at IQVIA, you will play a critical role in ensuring the successful execution of site activation activities in accordance with local and international regulations, standard operating procedures, and project requirements.Key Responsibilities* Serve as Single Point of Contact (SPOC) for investigative...
-
Business Development Manager
4 months ago
Solna Municipality, Sweden Talentor Sweden Full timeCompass Group är en världsledande leverantör inom mat, dryck och supportservice. Ända sedan Compass Group grundades under tidigt 1940-tal har ambitionen varit att skapa näringsrika måltider som ger god energi. Med hälsa och hållbarhet i centrum utvecklar vi menyer och matupplevelser som förser företag, industrier, försvaret, förskolor, skolor,...
-
Business Development Manager Hematology
6 days ago
Solna Municipality, Sweden GSK Full timeAbout the RoleWe are seeking a highly skilled Business Manager to drive the successful launch of Belamaf in Sweden. This is a unique people management role combining brand and sales management for part of the hematology portfolio in Sweden.Key ResponsibilitiesWork with the cross-functional team to create the strategic business plan and propose the strategic...
-
Solna Municipality, Sweden Orange Business Full timeAbout the Role:We are seeking a highly skilled Financial Data Expert to join our Business Control & Analytics team at Orange Business. As a Saleshub & Business Controller, you will play a pivotal role in managing financial data and business processes for Norway, Sweden, and Germany.Key Responsibilities:Provide expert analysis and insights to support business...
-
Solna Municipality, Sweden Orange Business Full timeAbout the Role:We are seeking a highly skilled Financial Data Expert to join our Business Control & Analytics team at Orange Business. As a Saleshub & Business Controller, you will play a pivotal role in managing financial data and business processes for Norway, Sweden, and Germany.Key Responsibilities:Provide expert analysis and insights to support business...
-
Solna Municipality, Sweden TD SYNNEX Sweden AB Full timeAbout the RoleWe are seeking an experienced Business Development Manager to join our team at TD SYNNEX Sweden AB. As a dynamic and results-driven professional with a passion for IT security, you will be responsible for identifying and capitalizing on new opportunities within the IT security domain.Key ResponsibilitiesBusiness Development Expertise: Develop...
-
Business Development Manager AWS
6 days ago
Solna Municipality, Sweden TD SYNNEX Full timeAbout TD SYNNEX: We are a Fortune 500 global corporation operating in over 100 countries, with a diverse workforce of 22,000 employees. As the world's largest IT distributor, our mission is to provide top-notch technology solutions, empowering businesses and individuals to navigate the digital world safely and efficiently. About the Role: As a Business...
-
Solna Municipality, Sweden TD SYNNEX Full timeAbout TD SYNNEX:We are a Fortune 500 global corporation, operating in over 100 countries, with a diverse workforce of 22,000 employees. As the biggest IT distributor in the world, our mission is to provide top-notch technology solutions, empowering businesses and individuals to navigate the digital world safely and efficiently.About the Role:We are seeking...
-
Solna Municipality, Sweden TD SYNNEX Norway AS Full timeAbout the Role:We are seeking a highly skilled Business Development Manager to join our team at TD SYNNEX Norway AS. As a Business Development Manager, you will be responsible for developing and executing strategies to drive sales growth and revenue for our consumer electronics and mobile phone products in the Nordic region.Key Responsibilities:Develop and...
-
Quality Assurance Specialist
6 days ago
Sundbyberg Municipality, Sweden Permobil Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Permobil. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our medical devices.Key ResponsibilitiesDevelop, manage, and review Quality Management System (QMS) processes to ensure compliance with medical...
-
Business Development Manager IT Security: Sweden
3 months ago
Solna Municipality, Sweden TD SYNNEX Sweden AB Full timeWhy Choose TD SYNNEX:As a Fortune 500 global corporation, operating in over 100 countries, TD SYNNEX values its diverse workforce of 22,000 employees. As the biggest IT distributor in the world, our mission is to provide top-notch technology solutions, empowering businesses and individuals to navigate the digital world safely and efficiently.About the...
-
Nordic Business Development Manager
1 week ago
Solna Municipality, Sweden TD SYNNEX Norway AS Full timeAbout the Role:We are seeking a highly skilled Business Development Manager to join our team at TD SYNNEX Norway AS. As a Business Development Manager, you will be responsible for developing and executing business strategies to drive growth and revenue in the consumer electronics market in the Nordic region.Key Responsibilities:Develop and maintain strong...
-
Solna Municipality, Sweden TD Synnex Full timeAbout the Role:We are seeking a highly skilled Business Development Manager to join our team at TD SYNNEX. As a Business Development Manager, you will be responsible for developing and executing business strategies to drive growth and revenue in the consumer electronics and mobile phone markets in the Nordics.Key Responsibilities:Develop and maintain strong...
-
Solna, Sweden Vattenfall Full timeAbout the job Shape the path towards fossil-free living. Are you ready to challenge the status quo, lead us down new paths and contribute to solving one of humankind's greatest challenges – climate change? We are searching for talented individuals to join us as International Trainees at Vattenfall. Help us lead the energy transition and make a...
-
Solna, Sweden Vattenfall Full timeAbout the job Shape the path towards fossil-free living. Are you ready to challenge the status quo, lead us down new paths and contribute to solving one of humankind's greatest challenges – climate change? We are searching for talented individuals to join us as International Trainees at Vattenfall. Help us lead the energy transition and make a...
-
Finance Manager
3 days ago
Sundbyberg Municipality, Sweden Air Liquide Full timeAbout the RoleNordic Infucare, a leading provider of specialized treatments, is seeking an experienced Finance Manager to join their team in Stockholm. As a key member of the finance team, you will be responsible for the financial operations of the entire Nordic business, reporting directly to the Chief Financial Officer (CFO).Key ResponsibilitiesFinancial...
