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Join to apply for the TMF SPECIALIST & R&D ARCHIVIST role at Almirall
Join to apply for the TMF SPECIALIST & R&D ARCHIVIST role at Almirall
About Almirall
We care. Through pharmaceutical innovation and a strong commitment to global healthcare partnerships, we are dedicated to providing the tools, knowledge and science to improve the health of patients worldwide. We research, develop, manufacture and market our own medicines as well as a portfolio of licensed products designed to respond to the needs of different therapeutic areas. Today, our products are available in over 70 countries, on 5 continents, through 15 affiliates. Find out how we work every day to help to transform lives through science.
About Almirall
We care. Through pharmaceutical innovation and a strong commitment to global healthcare partnerships, we are dedicated to providing the tools, knowledge and science to improve the health of patients worldwide. We research, develop, manufacture and market our own medicines as well as a portfolio of licensed products designed to respond to the needs of different therapeutic areas. Today, our products are available in over 70 countries, on 5 continents, through 15 affiliates. Find out how we work every day to help to transform lives through science.
Core Responsibilities
* Document Management:
* Documentation custody in proper environmental conditions
* Supervision of the reception, location, shipments and data entry of the R&D Documentation.
* Responses to document retrieval queries from R&D internal users.
* Management and maintenance of R&D Archive following SOPs and GXP in force.
* Publications subscriptions maintenance
* Compliance and Regulatory:
* Ensure that all records comply with regulatory requirements set by health authorities such as the FDA, EMA, and other international or local regulatory bodies.
* Maintain conditions for the safeguarding of valuable documents, including proper storage environments
* Serve as the primary point of contact for internal and external audit procedure for archived materials
* Assist in managing records retention schedules and disposal protocols to meet legal and business requirements
* Clinical Trial Master File Oversight
* Coordinate eTMF plan and update as appropriate during study in agreement with CRO and Almirall study team.
* Provide input to the eTMF related aspects in the Request for Proposals.
* Support documentation of the clinical studies that is uploaded into the eTMF is accurate, complete, attributable, legible, contemporaneous and original way.
* Support to CT transparency global compliance.
* Management of outsourced activities with the partner
* Keep registries administration and maintenance (Corporate Web, Pub.com, EudraCT and CT.Gov.)
* Support for the for internal and external document exchange during the contents review process to ensure SOP compliance and regulatory timelines.
Required Education And Experience
* A high school diploma is required; an associate or bachelor's degree in a related field is preferred
* Libraries/archives management software
* Familiar with the documentation generated in the R&D area of the pharmaceutic industry and in particular with clinical trials
* GxP knowledge and 5 years’ experience in using GxP compliance system for electronic documentation management and archiving
* User of office automation tools that help streamline office tasks.
Preferred Skills & Competences
* This role is essential for ensuring the integrity and accessibility of critical documentation, supporting compliance efforts, and preserving the company's historical records
* Strong understanding of pharmaceutical regulations, and the importance of maintaining corporate history for regulatory and business purposes.
* Proficiency in digital archival systems and metadata tagging.
* Leadership: Demonstrated ability to take decisions and communicate
* Adaptability: Ability to adapt to changing technologies and methodologies.
* Collaboration: Good interpersonal skills and ability to work effectively in a team environment.
* Passionate about cross-cultural environment and being able to interact with CROs and manage external providers.
* Strong interpersonal skills, including verbal and written communication, are requested.
* Be able to provide training and guidance to staff on best practices for records management and archiving
* Critical thinking to continue improvement of the information management, archival process, and systems based on KPIs and Metrics measurements.
Why work with Almirall?
We are a people-centric company where employees are at their best, patients and customer are at the heart of every decision, and our focus and agility allow us to deliver greater impact for all.
Additionally, for the 17th year in a row, we have been certified as Top Employer Spain, and also Top Employer Germany for the first time.
This strengthens our commitment to create a unique work environment that helps our employees to develop their skills to fullest and grow both professionally and as individuals.
We are delighted to have a great team that is proactive, innovative, and eager to transform the world of people with skin conditions.
We are proud of each one of our employees, their development, and growth: they are the success of the company.
Our purpose
"Transform the patients' world by helping them realize their hopes & dreams for a healthy life".
Our values
* Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
* Courage: we challenge the status quo, we take full ownership and we learn from our success & failures.
* Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
* Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
At Almirall, it’s all about people!
#wearealmirall
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Research and Science
* Industries
Pharmaceutical Manufacturing and Biotechnology Research
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