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Clinical Project Specialist - 24h week
Janssen Biologics BV (JBV) has a large business currently focused on four immunology drugs, Remicade, Simponi, Stelara and Tremfya, and one cardiovascular drug, ReoPro. It also has additional immunology drugs currently in development. For these drugs, JBV/Janssen is responsible for clinical development, manufacturing, and regulatory affairs. Commercial partners, such as sister company Janssen Pharma or external pharma companies, such as MSD, commercialize the drugs in Europe and around the world. JBV is also the Marketing Authorization Holder (MAH) in Europe and a number of other countries for Remicade, Simponi and ReoPro, as well as trial sponsor for certain studies in the EU with these drugs. Accordingly, it fulfills all legal and regulatory obligations related to its role as MAH and trial sponsor.
Het bedrijf / The company
Medical Affairs Europe (MA EU), is responsible for meeting the Medical Affairs responsibilities in Europe related to JBV"s status as MAH and trial sponsor and to its interests in the European market (Remicade, Simponi and ReoPro), including the conduct of trials, post-marketing regulatory commitments, pharmacovigilance and marketing compliance.
The (Jr) Associate Clinical Project Specialist responsibilities will include project support, project management and medical information activities. They will be responsible for management of the MA PMC group"s project-related planning, e-archiving of project-related documents and driving cross-functional integration of operational activities, including coordinating across workgroups, facilitating issue identification and resolution and contingency planning. Additionally, this individual will provide scientific support and clinical project management support for ongoing and new research activities (e.g. Company Sponsored Trials) including planning of contracting, study budget and data display.
Their activities will include (1) project management and operational support for observational studies (PASS, RWE) and IIS clinical trials, (2) tracking and planning of MA PMC contributions to regulatory related and safety related documents, (3) tracking of all JBV/JBI MA clinical programs, (4) project management and operational support for MA PMC data display activities, (5) creation of scientific material, gathering, digestion and distribution of relevant scientific information in support of the MA PMC team"s objectives (6) maintain MA PMC team folder with up to date project-related information, (7) management of interactions with GCO and the Clinical Project Management staff in US for study conduct and tracking. General responsibilities include (8) developing and maintaining expertise relevant to department"s activities, (9) building and maintaining therapeutic area expertise and (10) establishing productive working relationships with the department"s key stakeholders.
Janssen Biologics (7266)
De functie / The role
The (Junior) Associate, Clinical Project Specialist, reports to the Director, Post-Marketing Commitments and Pharmacovigilance. They have no direct reports.
Provides project management and operational support for observational studies (PASS, RWE) and IIS clinical trials in the immunology therapeutic area. This includes developing and maintaining timelines, facilitating company review and approval process (ReCAP), tracking of studies in the company study repository (JJAR), planning and tracking of contracts and invoices, preparing agenda and minutes for key meetings and tracking overall study progress.
Develops timelines and tracks all planned and ad-hoc regulatory submission- and safety related- documents involving authorship or review by the MA PMC team. These documents include study protocols and reports, clinical overview documents, health authority response documents, aggregate safety reports (PBRERs, IBs, DSURs,..), RMPs and safety review reports. S/he will develop a timeline with due dates for all planned documents and will add ad-hocs as they come in. S/he will also keep a tracker of all team documents with review/submission timelines, ERIS numbers and health authority assessments as available.
Keeps updated trackers of all JBV/JBI MA clinical programs with respect to status, budget and data display. He/she will provide regular status updates to the MA PMC Director.
Provides project management and operational support for JBV MA"s data display activities. This will include abstract planning & tracking and publication planning & tracking, as well as facilitating standard procedures for management review through PubStrat
Creates scientific material. The associate can be requested to research, analyze and translate scientific information into custom-made materials, such as summaries, overviews or slide kits, which support the team"s goals. These materials might be for either internal use or use with Merck or healthcare professionals.
Organizes and maintains the MA PMC team folder with up to date project-related information.
Serves as the key contact for MA PMC team"s interactions with IPV, GCO and the Clinical Project Management staff in the US for operational aspects of studies, including safety reporting and tracking
Establishes and maintains good working relationships with key stakeholdersresponsible for execution of clinical program activities. Holds or participates in regular meetings with all stakeholders
Develops and maintains expertise on company policies and procedures, as well as applicable national and European directives and policies, relevant to the department"s activities.
Builds therapeutic area expertise related to the company"s immunology products and disease areas of interest.
Het profiel / Your profile
This position requires considerable project management skills, attention for detail, ability to meet deadlines, willingness to work with ambiguity and complexity and ability to work independently. This role also requires a scientific background, a basic understanding of immunology and drug development as well as a genuine interest for the regulation and governance of clinical research. In addition, the position requires strong interpersonal skills to deal with a range of internal and external stakeholders.
Success in this position requires a range of professional and scientific skills, including:
project management skills, high degree of self-organization and attention for detail
excellent communication and organizational skills
ability to deal with ambiguity and deadlines
problem solving attitude and early, open communication in case of project issues or major hurdles that may impact the successful trial/project outcome.
strong interpersonal skills for negotiating timelines and for effective interactions with international and multidisciplinary members of the organization
knowledge of the Immunology field (rheumatology, gastroenterology, dermatology) where biologicals are used. Willingness to build product and disease-state knowledge through independent reading and training provided by the Medical Affairs team members
ability to work independently within a remote team without daily supervision is a plus
previous knowledge of regulatory and business requirements is a plus
In this position, you will work with all functional areas of Medical Affairs (EU and US), EMEA Regulatory Affairs, our Global Clinical Operations teams, Global medical Safety, HR and J&J in all of EMEA. Besides these internal groups, you will work with different externals such as Health Care Professionals and Institutions, other commercial business partners, employment agencies and services agencies.
Minimum Education and Work Experience
University degree in life sciences (BS/MS).
Minimum 2 years of working experience, ideally in a pharmaceutical company
Professional Skills and Requirements
Experience with most of the activities listed in the principle responsibilities
Fluency in written and spoken English; fluency in Dutch desired
Ability to travel 10% of the time
Ability to work from the Leiden office
Standard computer skills
Strong sense of personal and professional ethics
Demonstrated learning ability
Entrepreneurial spirit and creativity to launch new projects
Excellent interdependent partnering skills to participate to cross-functional teams and projects across various companies
Ability to work both independently; ability to make independent decisions and function with ambiguity
Competence in dealing with a wide range of internal and external contacts, including a strong customer orientation
Excellent organizational, communication, and management skills, in the context of handling multiple projects simultaneously
Ability to drive department objectives tactically with attention to detail where needed
Ability to manage and influence with and without direct authority