Clinical Trials/Regulatory Affairs in Pharma Industry

Dfind Science & Engineering AB / Apotekarjobb / Göteborg
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Clinical trials/Regulatory Affairs
For future assignments within the Pharmaceutical or Med Tech industry we are now looking for consultants in Clinical Trials and Regulatory Affairs. Do you have experience in one or both of these areas?

You will get employed by Dfind Science & Engineering and work with one of our clients within the Pharmaceutical or Med Tech industry.

Clincal Trials - there are different roles linked to Clinical Trials, but the overall responsibilities are:

• Plan, lead and coordinate the set-up and conduct of clinical trials in phase I-III
• Collaborate with different stakeholders and CROs to ensure that the trials are run in accordance with GCP, time plan and budget.
• Review and compile clinical data
• Monitor compliance of study conduct and processes
• Handle and compose documents related to clinical trials, in accordance with requirements from the authorities
• Implement agreed strategies including processes and use of technical systems

Regulatory Affairs are responsible for project management and coordination of the content of all regulatory submissions sent to health authorities and ensure that products meet all legal requirements, both regarding new products as well as for new indications, new markets license renewal, etc. A role within regulatory affairs may include:

• Prepare and deliver regulatory operational plans for allocated projects/products.
• Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents
• Ensure high technical quality of regulatory documentation submitted to health authorities.
• Work flexibly within and across Therapeutic Areas to provide broad regulatory support to ensure the delivery of product team and business objectives.
• Identify potential regulatory risks to the operational plans, and propose options to mitigate risks.
• Contribute to solutions to regulatory issues.

Please, clearly specify in your application which area your qualifications apply to.

Minimum Requirements

• Scientific degree e.g. Engineering, Biotechnology, Molecular Biology, Pharmacist
• Experience from the pharmaceutical or med tech industry
• Comprehensive understanding of the pharmaceutical/drug development process
• Good communicator with experience of interacting effectively across interfaces
• Excellent written and verbal communication skills
• Strong collaboration skills
• Fluent in written and spoken English

Preferred experience/requirements

• At least 2 years of experience of working with Clinical Trials and/or Regulatory Affairs
• Good knowledge of Clinical Development processes
• Strong negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.
• Capable of making effective decisions
• A high degree of personal credibility

Personal Qualities

We put high importance in personal qualities. Candidates should possess good social skills and be strong team players. You should be able to work independently, take own initiatives and have a positive, goal oriented and problem solving attitude. It is essential to have good organizational and communication skills.

Business: Dfind Science & Engineering

City: Göteborg

Deadline for application: 2018-04-30. Since selection is done continuously we prefer receiving your application as soon as possible.

More information: Birgitta Nyström at birgitta.nystrom@dfind.se [ mailto:birgitta.nystrom@dfind.se ]

Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.

Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the work second largest company within recruiting and staffing.

Varaktighet, arbetstid
Heltid Tillsvidare

Publiceringsdatum
2018-04-20

Ersättning
Fast lön

Så ansöker du
Sista dag att ansöka är 2018-05-01
Ange följande referens när du ansöker: 201143529
Klicka på denna länk för att göra din ansökan

Kontakt
Birgitta Nyström

Företag
Dfind Science & Engineering AB

Adress
Dfind Science & Engineering AB
Östra Hamngatan 23
41110 GÖTEBORG

Kontorsadress
Östra Hamngatan 23, 41110 GÖTEBORG

Jobbnummer
4098482

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