Associate, Submissions Management

Dieses Inserat ist leider ausgelaufen
Aber es warten noch tausend andere spannende Inserate auf Dich.
Neue Suche starten

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for an Associate, Submissions Management with experience in safety report submissions, document publishing and administrative support, to be part of the Pulmonary Hypertension (PH) therapeutic area team within Regulatory Submissions Management and Operations. This position is based in Allschwil, Switzerland.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension, cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

Associate Submission Management

The Associate, Submission Management:

  • Is responsible for the management and delivery of regulatory submissions (primarily safety reports) to global health authorities required to support the development and registration of products
  • Utilizes current electronic document management systems/tools to assemble and/or publish dossiers according to regulatory requirements for paper and electronic submissions
  • Ensures dispatch/distribution in compliance with due dates to Health Authorities, Local Operating Companies and Business Partners, as applicable, tracking submission events/activities in appropriate systems/tools
  • Where appropriate, provides component-level publishing support for regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (e.g., bookmarking, linking, PDF version)
  • Applies appropriate regulatory submission standards, requirements, processes, and policies to ensure compliance with applicable internal and external Health Authority guidelines
  • Tracks document status inside Dossier Plans with functional area owner
  • May interact with regulatory therapeutic areas, functional area representatives, and key stakeholders. Facilitates meetings as needed
  • Supports development of departmental work practices, process enhancements/improvements, and associated training materials
  • Represents department on Janssen initiatives where appropriate
  • Develops/maintains associated process tools and relevant training documentation
  • Supports compliance needs and participate in internal audits/external inspections as appropriate
  • Provides administrative support to department, as needed.

Qualifications

Qualifications:

  • A minimum of a University/Bachelor’s Degree or equivalent degree and 1-3 years of relevant/related professional experience is required
  • Experience associated with managing or publishing of global regulatory submissions, especially safety reports, document level publishing and providing administrative support is highly preferred
  • Therapeutic area and product knowledge is highly preferred
  • Understanding of drug development process is preferred
  • Project or submission management capabilities is highly preferred
  • Effective interpersonal, teamwork, and communication skills are required
  • Ability to work or lead in a matrix environment is required
  • Ability to build productive relationships across an organization is required
  • Knowledge of relevant submission-related Health Authority and Industry regulations and guidelines is required - particularly with regards to safety reporting
  • Problem solving capability, including trouble shooting and adaptability are required
  • Fluency in English is required; proficiency in other languages may be an advantage
  • This role will be based in Allschwil, Switzerland.

Primary Location
Switzerland-Allschwil– Organization
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)
Job Function
Submissions
Requisition ID
1905749545W

Am 19.07.2019 veröffentlicht. Originalanzeige