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Submission Manager

Submission Manager

RochePenzberg, Bavaria, Germany
Vollzeit
The Submission Manager delivers high quality regulatory submissions to Health Authorities worldwide.They edit complex technical documents. They have responsibilities for varying regulatory submissio...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
Production Planner (w / m / d)

Production Planner (w / m / d)

Qioptiq Photonics GmbH & Co. KGRegen, Landkreis Regen; Region Donau-Wald, Bayern; Regierungsbezirk Niederbayern; Bayern, Germany
Bei Excelitas bieten wir eine Kombination aus Grund- und flexiblen Vergütungen an, die sich an allen unseren weltweiten Standorten unterscheiden. Unser umfassendes Leistungspaket ist länderspezifisc...Mehr anzeigenZuletzt aktualisiert: vor 1 Tag
  • Gesponsert
Senior Specialist GMP Services (gn)

Senior Specialist GMP Services (gn)

headwaypersonal GmbHPenzberg, DE
HEADWAY – Ihr Experte in der Personalbranche mit mehr als 20 Jahren Erfahrung.Seit unserer Gründung im Jahr 1997 arbeiten wir stets daran, uns zu verbessern, um unseren Kunden, Mitarbeitern und Par...Mehr anzeigenZuletzt aktualisiert: vor 22 Tagen
Material Planner (m / w / d)

Material Planner (m / w / d)

emersonBavaria, Germany
In unseren Niederlassungen in der Schweiz, Deutschland, China und USA entstehen Produkte, die in allen produzierenden Branchen zum Einsatz kommen. Von Automotive über Konsumgüter, Lebensmittel, Masc...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
Team Executive Assistant mfd

Team Executive Assistant mfd

Signature Ventures GmbHMünchen, Bavaria, Germany
Partor FullTime Team & Executive Assistant in Venture Capital.Headquarters near Munich in Aying.Minimum of 20 hours per week up to fulltime. Start : Flexible as soon as possible.Are you up for a...Mehr anzeigenZuletzt aktualisiert: vor 25 Tagen
Project Manager (m / f / d)

Project Manager (m / f / d)

ExytePenzberg
As one of us, you will contribute to engineering excellence for the high-tech markets of the future, including semiconductors, batteries, pharmaceuticals, biotechnology, and data centers.At Exyte, ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Senior Specialist GMP Services (m / w / d)

Senior Specialist GMP Services (m / w / d)

HEADWAY PenzbergDeutschland, Bayern, Penzberg
Vollzeit
Quick Apply
HEADWAY - Ihr Experte in der Personalbranche mit mehr als 20 Jahren Erfahrung.Seit unserer Gründung im Jahr 1997 arbeiten wir stets daran, uns zu verbessern, um unseren Kunden, Mitarbeitern und Par...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Auszubildender Kaufmann für Marketingkommunikation (w / m / d) ab 2025

Auszubildender Kaufmann für Marketingkommunikation (w / m / d) ab 2025

Haas FertigbauNiederbayern
Einsatzort 84326 Falkenberg Region Niederbayern Einstellungstermin 01.Arbeitszeit Vollzeit Einstiegsart Ausbildung Arbeitsbereich Verwaltung. Dabei steuerst Du die gesamte Umsetzung der Maßnahmen : D...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Senior Engineer HVAC Biopharma Life Science (m / f / d)

Senior Engineer HVAC Biopharma Life Science (m / f / d)

EXYTE GMBHPenzberg, Bavaria, Germany
As one of us, you will contribute to engineering excellence for the high-tech markets of the future, including semiconductors, batteries, pharmaceuticals, biotechnology, and data centers.At Exyte, ...Mehr anzeigenZuletzt aktualisiert: vor 20 Tagen
Event Freelancer (m / w / d)

Event Freelancer (m / w / d)

Specialized Germany GmbHGermany, Holzkirchen
Specialized wurde 1974 von Bikern für Biker gegründet.Die Marke mit Hauptsitz in Kalifornien hat es sich zum Ziel gesetzt, funktionelle und technisch fortschrittliche Produkte zu entwickeln, die ei...Mehr anzeigenZuletzt aktualisiert: vor 7 Tagen
1,5 jährige Ausbildung zum Qualifizierten Pflegeassistent (m / w / d) im Pflegeheim Lappersdorf in Lappersdorf

1,5 jährige Ausbildung zum Qualifizierten Pflegeassistent (m / w / d) im Pflegeheim Lappersdorf in Lappersdorf

Kursana-GruppeBayern, DE
Starten Sie Ihre Ausbildung bei einem global operierenden Multidienstleister und werden Sie Teil eines Teams von über 63. Dauer : Je nach Bundesland 12, 18 oder 24 Monate in Vollzeit.Perspektive : Die...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
IoT Backend Developer

IoT Backend Developer

Concept Reply GmbHPenzberg, Germany
Kenntnisse in der Softwareentwicklung in Java, JavaScript / Node.SQL / noSQL Datenbanken und Cloud Computing (Azure, AWS). Grundlegende Erfahrung in Web-Technologien wie JavaEE, Spring, Websocket un...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Mitarbeiter Qualitätssicherung Roche (gn) (60000.00€ - 70000.00€ / year)

Mitarbeiter Qualitätssicherung Roche (gn) (60000.00€ - 70000.00€ / year)

Trenkwalder DeutschlandPenzberg, DE
Quick Apply
Unser Kunde, die Roche Diagnostics GmbH, ist mit rund 15.Mitarbeitern (m / w / d) an mehreren Standorten in Deutschland vertreten. Als führendes Unternehmen im Bereich der Pharma und Diagnostik entwicke...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Compliance Specialist (m / f / d)

Compliance Specialist (m / f / d)

GULP – experts unitedPenzberg
Are you looking for a new and varied role in which not only your specialist knowledge but also your ability to work in a team and motivation are valued? Then our team of experts at Randstad profess...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Submission Manager

Submission Manager

RochePenzberg, Bavaria, Germany
Vor 30+ Tagen
Anstellungsart
  • Vollzeit
Stellenbeschreibung

The Position

The Submission Manager delivers high quality regulatory submissions to Health Authorities worldwide. They edit complex technical documents. They have responsibilities for varying regulatory submission projects, as business needs dictate. They apply submission management skills to their work and contribute to the daily business of Pharma Technical Regulatory submissions. They have the knowledge and ability to work with all submission types across Health Authorities globally.

Primary duties and responsibilities :

Edit complex technical documents for clarity, grammar, spelling, and punctuation. Ensure adherence to applicable regulatory CTD) and Roche guidelines

Manage the flow of information and input of data into the regulatory information management system, ensuring data accuracy and maintaining data quality

Support and provide coordination, compilation and submission management in the preparation of new and existing regulatory applications, in compliance with health authority regulations

A key member of local filing teams, provide ongoing expertise regarding regulatory submissions and guidance on compliance, timing and other relevant matter

Facilitates communication and collaboration to meet submission timelines and plan future requirements.

Manage the flow of documents via document-sharing systems SharePoint) and document management-systems Documentum) and ensure version control throughout the submission generation process (writing, review, and internal approval)

Communicate with technical subject-matter experts to ensure content is delivered according to schedule and provide status updates.

Coordinate and provide training on documentation systems and tools and collect relevant submission related data

Facilitate submission reviews and review adjudication meetings and perform live editing to capture stakeholders’ decisions

Collaborate with internal partners Regulatory Publishing, Project Management, Business Systems, etc.)

Providing input on future system enhancements, business process updates, and submission model documents

Additional responsibilities :

Facilitate knowledge sharing and best practice workshops contributing to continuous improvement

Lead or is an active member of teams for special or ongoing initiatives and project

Participates in and / or otherwise supports development and implementation of new or updated PTR and / or -specific systems, processes, or other relevant tools.

Includes supporting user acceptance testing for new or updated systems or electronic tools

Ability to travel and work internationally

Quality Related Job Accountabilities :

Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PT and PTR. Expected to develop and maintain his / her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.

Contributes to development and maintenance of policies and / or Standard Operating Procedures and related document management processes.

Ensure compliance with Roche standards, ICH, and other guidelines for incorporation into eCTD submissions

Follows regulations and company policies, and complies with all Roche Standard Operating Procedures

Demonstrates a continuous improvement mindset, with identifying and recommending opportunities to streamline or improve processes

Qualifications :

Minimum BA or BS (or equivalent) in English, biology, chemistry, pharmacy, or related field

Proficiency in RIM - Regulatory Information Management system - preferred but not mandatory

Strong track record as an editor , including at least three years of professional experience, in a scientific or technical field preferred but not mandatory

Previous experience with regulatory documents in CTD structure and other ICH, FDA, and EMA guidelines) and global submission dossiers or in the biotech or pharmaceutical industry is beneficial

Expert-level use of Word, Excel, PowerPoint, and Adobe Acrobat and experience with document management systems Documentum) and document sharing systems SharePoint)

Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders, including PTR submission leads, scientific subject-matter experts, reviewers at all levels and colleagues located in other countries

Strong organizational and time management skills and ability to deliver under pressure and work flexibly to support changing assignments and priorities in an independent and reliable manner

Competencies and Skills :

Strong written and verbal communication skills

Listens well and expresses ideas fluently and eloquently, is open to the input of others, can be depended on to tell the truth regardless of the circumstances

Understands the perspectives of different functional areas in the organization

Gathers information and thinks through problems clearly and logically, and makes timely decisions

Effectively manages change; explaining the context, answering questions, and patiently listening to concerns

Project management : consistently achieves multiple tasks and goals on-time

Proactively manages issues as, or before, they arise

Recognizes and rewards hard work and dedication to excellence contributions of peers).

Fosters an exchange of ideas and support amongst colleagues

Able to help others link and prioritize their work with the mission of PTR and Roche

Articulates long-term objectives and strategies, and is good at promoting an idea or vision

Application period until at least : 21st Nov 2023 (application possible as long as the position is advertised)

Your application

You only need to upload your CV. Further documents will be requested if required.

Refer a Friend!

This position is eligible for a bonus as part of our Refer a Friend program for Roche employees in Germany. In the event of a successful referral, a bonus will be paid in accordance with the applicable regulations and conditions.

Your