(Sr.) Manager Business Process Coordinator

Країна: Нідерланди;

Місто: Leiden

Додана: 04.09.2015

Роботодавець: Astellas Pharma

Тип: PhD position; Vacancy for students or masters;

Для кого: For administrators;

 

Do you have a Bachelor’s degree and at least six years experience in the industry and at least four years experience in Regulatory Operations or closely associated with health authority regulations? And do you have a strong proficiency in business process management? Then Astellas has two interesting job opportunities for you!

The job

We have two positions; a senior manager Business Process Coordinator and a manager Business Process Coordinator. The primary purpose of these positions is to coordinate various activities related to the collection, organization and dissemination of regulatory submissions. These roles are primarily focused on planning and tracking regulatory submissions globally. You will plan and track maintenance submissions and help define and report on related KPIs such as submission timeline compliance by Affiliates and Clinical Trial Data Disclosure obligations.

The (senior) manager will organize and coordinate information exchange among Regulatory Affairs functions as well as stakeholder groups such as Quality Assurance and Manufacturing. You will address complex and diverse challenges with decision-making that impacts multiple projects, functional and therapeutic areas. Also you will identify changing regulatory guidance and anticipate impact on submission preparation and processing or other information management activities.

We offer

  • A challenging and diversified job in an international setting;
  • Good career opportunities;
  • Inspiring and dynamic work climate in a new and state of the art working environment;
  • Attractive remuneration, which include a 13th month, bonus scheme, excellent pension policy, 25 Holidays + 13 so called ADV Days, if applicable an attractive relocation package and more.

Your personal qualifications

  • Bachelor’s degree;
  • At least 6 (7 for the senior position) years of previous industry experience; 4 in Regulatory Operations or in a role closely associated with interpretation of health authority regulations, product change control, labeling, submission publishing, or registration tracking;
  • Supervisory experience;
  • Familiarity with relevant regulation, interpreting regulatory guidance and monitoring the external regulatory environment for changes that impact submission standards or other regulatory practices;
  • Ability to communicate effectively, establish and maintain productive working relationships, and influence peers and others within the organization;
  • Strong proficiency (or proven expertise for the senior position) in project management software, e.g. Microsoft Project;
  • Familiarity (or strong proficiency for the senior position) in registration tracking, submission planning and document management systems and concepts;
  • Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple diverse projects simultaneously;
  • Excellent written and verbal communication skills (native and non-native English speakers) with the ability to meet regulatory requirements and standards while maintaining effective relationships;
  • Ability to plan and manage his or her own tasks as well as for others;
  • High integrity with respect to maintenance of proprietary, confidential information;
  • Strong decision-making and problem-solving skills;
  • Composure under pressure.

Preferred

  • Bachelor’s degree in scientific discipline; advanced degree;
  • Experience using document management software, e.g. Documentum;
  • Experience using electronic publishing software, e.g. eCTDXPress or docuBridge;
  • Proficiency in Spanish;
  • Experience using Structured Product Labeling software, e.g. from i4i (only for senior level);
  • Experience using regulatory information tracking software, e.g. from ArisGlobal, Liquent, CSC or Lorenz (only for senior level);

At Astellas, we believe that nurturing a good relationship with our employees delivers good business results. It is our stated aim in VISION 2015 for Astellas to be recognised as an employer of choice. This means ensuring we are a highly effective organisation, that applies best-in-class people management, creates a positive working environment and has an inspirational company culture. Through ongoing research and by regularly consulting our employees, we are able to define our commitment using our Employee Value Proposition. This reflects the working culture of Astellas, outlines our expectations as an employer and captures the essence of our company ethos; CHANGING TOMORROW.

About Astellas

Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 8 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,300 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Dermatology, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products. Astellas employs around 850 persons in the Netherlands at Leiden and Meppel.

Mirai House, located in Leiden Bio Science Park, is home to a number of divisions, including the European R&D organization focusing on the development of medicines in the areas of Urology, Nephrology, Pain, and Diabetes/Metabolic diseases. It is the location where the majority of offices and clean rooms & labs are located.

Interested?

Apply via the link.

Click here to apply!

 
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