Regulatory Project Assistant

3 weeks ago

Montréal, Canada Innovaderm Research Full time

The Regulatory Project Assistant (RPA) is responsible for providing project administrative support to the the regulatory and scientific project team members (regulatory affairs, eTMF operations, medical writing, pharmacovigilance, and medical monitoring). The RPA properly manages personal timelines and workload distribution between short term and long term deliverables such that all project deadlines are respected.

**Please note this position is a one year contract**

**This role will be perfect for you if**:

- You want to have an experience in regulatory and scientific affairs;
- You want to work in a collaborative environment;
- You want to have an impact in a fast-growing company.

**RESPONSIBILITIES**
- Prepares investigator study files (compilation of essential documents electronically for ISF build)
- Assists with initiating and maintaining study files (eTMF)
- Reconciles eTMF user access lists against employee list.
- Download approval letters, communications, and approved documents from IRB portal and send for upload to eTMF
- Supports user requests and site creation for IRB portals
- Prepare project documentation for ethics and regulatory submissions
- Prepares and updates regulatory tracker for assigned studies
- Verification, reconciliation, and tracking of vendor invoices for ethics and translation
- Compile and format Clinical Study Reports (CSRs) and appendices as per requirements for electronic submissions (eg, bookmarks, hyperlinks, eCTD).
- Assists with tracking of medical monitoring communications
- Assists with project tracking activities and status reports preparation
- Participates in various administrative tasks, as required, to accomplish the goals of the project and the needs of the project teams

**Requirements**:
**IDEAL PROFILE**

**Education**
- Relevant education in science or clinical research

**Experience**
- At least 1 year of experience working in an administrative support-type of role/clinical research;
- Experience in the biotechnology, pharmaceutical, and/or CRO industry.

**Knowledge and skills**
- Knowledge and competency with PDF editor software
- Knowledge and competency in Word, Excel, and Outlook
- Quick learner.
- Multi-tasking skills;
- Attention to detail and accuracy in work.
- Ability to work in a fast-paced evolving and global environment

Our company:
**OUR COMPANY**

**The work environment**

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

As a Project Coordinator, you will be eligible for the following perks:

- Flexible work schedule
- One year contract
- Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
- Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)
- Possibility of working from home in accordance with company policies and public health directives
- Ongoing learning and development

**About Innovaderm**

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.

**_
Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request._**

**_ Innovaderm only accepts applicants who can legally work in Canada._

  • Regulatory Specialist

    7 days ago

    Montréal, Canada Excelgens Full time

    op Qualifications: Regulatory and Product Compliance background, Safety/RF knowledge in Information Technology Equipment (ITE), which means computer hardware Job Summary: As part of the Zebra Enterprise Visibility and Mobility (EVM) Regulatory department, this role is to provide Regulatory support for new product development as well as continued compliance...

  • Project Regulatory Specialist

    3 weeks ago

    Montréal, QC, Canada Sagard Holdings Management Inc. Full time

    La version française est ci-dessous. Sagard is a multi-strategy alternative asset management firm active in venture capital, new venture creation, private equity, private credit, real estate, royalties with $14.5B in assets under management. Sagard also engages in private wealth management through its ecosystem partner Grayhawk. We are looking to hire a...

  • Regulatory Affairs Manager

    2 weeks ago

    Montréal, QC, Canada Lock Search Group Full time

    Regulatory Affairs Manager Montreal or Quebec City, Quebec Our client, a medical device company specializing in the production of various medical equipment and healthcare products, is in search of a Pre-Market Regulatory Affairs Manager. The incumbent will deliver the regulatory strategy and regulatory plans throughout the design and development process...

  • Director, Medical/Regulatory Writing

    4 days ago

    Montréal, QC, Canada Lock Search Group Full time

    Regulatory Affairs Manager Our client, a medical device company specializing in the production of various medical equipment and healthcare products, is in search of a Pre-Market Regulatory Affairs Manager. The incumbent will deliver the regulatory strategy and regulatory plans throughout the design and development process of new products. Working closely...

  • Director, Medical/Regulatory Writing

    3 weeks ago

    Montréal, QC, Canada Lock Search Group Full time

    Regulatory Affairs Manager Montreal or Quebec City, Quebec Our client, a medical device company specializing in the production of various medical equipment and healthcare products, is in search of a Pre-Market Regulatory Affairs Manager. The incumbent will deliver the regulatory strategy and regulatory plans throughout the design and development process...

  • Regulatory Affairs Manager

    1 week ago

    Montréal, QC, Canada EightSix Network Inc Full time

    Our client, a medical device company specializing in the production of various medical equipment and healthcare products, is in search of a Pre-Market Regulatory Affairs Manager. The incumbent will deliver the regulatory strategy and regulatory plans throughout the design and development process of new products. Working closely with North American and...

  • Regulatory Affairs Manager

    3 weeks ago

    Montréal, QC, Canada Lock Search Group Full time

    Regulatory Affairs Manager Montreal or Quebec City, Quebec Our client, a medical device company specializing in the production of various medical equipment and healthcare products, is in search of a Pre-Market Regulatory Affairs Manager. The incumbent will deliver the regulatory strategy and regulatory plans throughout the design and development process...

  • Regulatory Affairs Manager

    4 days ago

    Montréal, QC, Canada Lock Search Group Full time

    Regulatory Affairs Manager Montreal or Quebec City, Quebec Our client, a medical device company specializing in the production of various medical equipment and healthcare products, is in search of a Pre-Market Regulatory Affairs Manager. The incumbent will deliver the regulatory strategy and regulatory plans throughout the design and development process...

  • Director, Medical/Regulatory Writing

    1 week ago

    Montréal, QC, Canada EightSix Network Inc Full time

    Our client, a medical device company specializing in the production of various medical equipment and healthcare products, is in search of a Pre-Market Regulatory Affairs Manager. The incumbent will deliver the regulatory strategy and regulatory plans throughout the design and development process of new products. Working closely with North American and...

  • Regulatory Affairs Associate

    7 days ago

    Montréal, Canada IFRS Foundation Full time

    **Location**: Beijing (PR of China), Frankfurt am Main (Germany) or Montreal, Quebec (Canada) preferred (office-based role, with flexible, hybrid office/home working offered) **Duration**: Permanent or fixed term secondment **Salary**: Competitive, plus benefits **Hours**: Full-time **About the role**: **Team**: The Regulatory Affairs team is intended to be...

  • Regulatory Compliance Program Director

    1 day ago

    Montréal, Canada Aylo Careers Full time

    Established in 2004, we are a tech pioneer offering world-class adult entertainment and games on some of the internet's safest and most popular platforms. With the support of an international team of dynamic and collaborative innovators, we are on a mission to enable safe user experiences and empower our communities by celebrating diversity, inclusion, and...

  • Advisor, Legal and Regulatory Compliance

    4 days ago

    Montréal, Canada Desjardins Full time

    Temporary position for 12 months. As a legal and regulatory compliance advisor, you help design, institute and coordinate the compliance framework and enforce related rules. You help ensure that oversight measures such as officer and employee behaviours comply with the organization’s standards. You advise and assist clients and partners as part of...

  • Senior Specialist CMC, Global Regulatory Affairs

    2 weeks ago

    Montréal, QC, Canada Pharmascience Full time

    Description : The Senior Specialist CMC assumes responsibilities to ensure the completeness of CMC documentation for all product dossiers and timely market approvals. He/she will also take part in the evaluation of new opportunities and other cross-functional projects. The ideal candidate is highly organized with a desire and ability for continuous...

  • Advisor, Regulatory Risk Management

    6 days ago

    Montréal, Canada Laurentian Bank Full time

    Seeing beyond numbers **TM** At Laurentian Bank, we believe we can change banking for the better. Founded in Montreal in 1846, Laurentian Bank helps families, businesses and communities thrive. Today, we have over 2,800 employees working together as One Team, to provide a broad range of financial services and advice-based solutions for customers across...

  • Junior Analyst

    6 days ago

    Montréal, Canada Maples Group Full time

    **Position**: Junior Analyst - Regulatory Services (AEOI) **Location**:Montreal, Canada **Who We Seek** Our merit-based culture suits professionals in pursuit of boundless careers and lives. Beyond their acumen, team members are collaborative and conscientious, bringing a healthy sense of drive and purpose to each interaction and to all aspects of their...

  • Manager, Fleet Regulatory and Administration

    7 days ago

    Montréal, Canada Canadian National Railway Full time

    At CN, everyday brings new and exciting challenges. You can expect an interesting environment where you’re part of making sure our business is running optimally and safely―helping keep the economy on track. We provide the kind of paid training and opportunities that long-term careers are built on and we recognize hard workers who strive to make a...

  • Finance & Accounting - Auditor

    4 weeks ago

    Montréal, QC, Canada Canadian Investment Regulatory Organization Full time

    Financial and Operations Compliance Examiner (ID) Financial and Operations Compliance Permanent Full-time (Hybrid) The Examineris accountable for analyzing and independently verifying the accuracy and completeness of the submitted information by member firms within the context of the regulatory reporting framework. Perform complex field examinations...

  • Project Manager

    5 days ago

    Montréal, Canada SmartCentres Full time

    **Job Title**: Project Manager - East **Reports To**: VP Construction & Special Projects **Department**: Construction Position Summary Oversee and manage commercial, residential and retail construction projects within the Portfolio. Responsible for the overall project performance as related to costs, schedule, quality and customer service while adhering...

  • Project Manager

    6 days ago

    Montréal, Canada Sierra business solution LLC Full time

    **Role: - Project Manager** **Rate: - 55 to 60/hr. CD** **Location: - Montreal ,Canada** **Duration: - Long Term** **Job Description: - ** We seeking a Project Manager to manage the implementation of IT requirements for the regulatory mandate to supply UPI (Unique Product Identifier) on select derivatives transactions. This project is in flight...

  • Industrial Development Project Manager

    4 weeks ago

    Montréal, QC, Canada ZenithNet-Zero Full time

    Position Overview: The Carbon Offset Project Development role involves identifying, evaluating, and implementing projects that generate carbon offsets, contributing to efforts to mitigate climate change. This position requires a combination of project management, technical expertise, and stakeholder engagement skills to develop and execute carbon offset...