Remote Ai Video Producer (Mid-Level) - High Autonomy

David Kennedy Recruitment; Buenos Aires; Remote; ARS 68,366,000 - 106,347,000; Full time

Job summary

IQVIA is seeking a Regulatory Affairs Officer at a mid-level to support regulatory submissions across markets. Based in Argentina with exposure to Peru and Colombia, you will prepare and review regulatory documents, track timelines, and support labeling/publishing activities under supervision.

The ideal candidate has 2–3 years in regulatory affairs, fluent English, and strong communication skills. A Lifescience degree and cross-country collaboration are required.

Qualifications

• Bachelor's Degree in Lifescience or related discipline.
• 2-3 years regulatory affairs (postmarketing) experience.
• 1 year tracking information on regulatory processes.
• Fluent English in speaking, reading and writing.
• Experience with USA/Canada is a plus.
• Strong interpersonal communication and organizational skills.
• Advanced knowledge of regulatory processes and publishing tools.
• Applicable certifications/licenses as required by country.

Responsibilities

• Act as Regulatory Team Member on small projects under senior guidance.
• Identify project needs, track timelines, and manage day-to-day workload with senior staff.
• Prepare/review regulatory documentation in area of expertise.
• Participate in project teams and present material in client meetings by phone or in person.
• May prepare and deliver trainings under senior guidance.
• Perform other tasks delegated by Regulatory management.
• Make minor changes in systems and processes to improve efficiency.

Skills

Regulatory knowledge

Postmarketing

English fluency

Country experience (USA/Canada)

Interpersonal skills

MS Office

Education

Bachelor's degree Lifescience or related

Tools

Microsoft Office

Job description

Regulatory Affairs Officer (Mid Level Role)

Lima, Peru
Buenos Aires, Argentina
Bogota, Colombia
Full time
R
**Job Overview**
Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects.
**Essential Functions**

• Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff;
• Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate;
• Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
• Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters;
• Understands the Scope of Work, deliverables for any given project;
• May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person;
• May prepare and deliver trainings, as appropriate;
• Performs other tasks or assignments, as delegated by Regulatory management;
• Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex;

**Qualifications**

• Bachelor's Degree in Lifescience or related discipline.
• 2-3 years of regulatory affairs (postmarketing) experience: maintenance records, new records, regulatory activities.
• 1 year tracking information on regulatory processes.
• Fluent English: Spoken, Read and Written.
• It's a plus to have worked with other countries: USA, Canada.
• Good, solid interpersonal communication (oral and written) and organization skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable.
• Demonstrates self-motivation and enthusiasm.
• Ability to work on several projects, with direction from senior staff as appropriate.
• Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements.
• Ability to make decisions on discrete tasks under senior supervision.
• Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.
• Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area.
• Problems faced are general and may require understanding of broader set of issues, but typically are not complex.
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Clinical Research Associate I - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to perform and coordinate different aspects of the clinical monitoring and site management process. As a Clinical Research Associate I, you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
What You’ll Do:

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required.

Education and Experience Requirements:

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job in a clinical environment where experience is gained in clinical trials, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
• Valid driver's license where applicable.
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Basic