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Job Information

ThermoFisher Scientific Principal Operational Quality and Compliance Specialist - 12 months FTC in Remote, Bulgaria

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

Business Enablement - Operational Quality and Compliance brings together colleagues from across the division including: project delivery, clinical operations, pharmacovigilance, regulatory affairs, medical writing, business transformation services, and the clinical development academy. Our team is accountable for ensuring consistent, effective and efficient business practices with a focus on eTMF, SOPs and written standards, business continuity planning, audit support, risk and issues management, and compliance.

The position offers 100% remote working flexibility.

This is a 12 months fixed term contract.

Discover Impactful Work:

  • Proactively collaborates with initiative leads and senior management to prepare, organize, coordinate, document and/or provide the development and delivery of department products and services to a globally dispersed, cross-functional audience in support of business outcomes and industry compliance requirements.

  • Provides guidance and reviews or creates varied support materials, presentations, and/or tools to support department's remit and strategies.

  • Proactively collaborates with initiative leads and senior management to develop, optimize and improve processes, associated systems/applications, training and communications.

  • Leads large scale, complex process improvement initiatives.

  • Skillfully develops process improvement processes and solutions.

  • Proactively identifies and collates information required to assess compliance with processes and to prioritize business process improvement needs.

  • May review, assess and update procedural documents for overall compliance with current processes.

  • Performs special projects, assignments and administrative tasks per business needs.

  • Mentors, coaches, and supports team members in developing and implementing process improvement initiatives.

Keys to Success:

Education

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

  • Significant clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

  • Broad understanding of procedural documents

  • Excellent understanding of process improvement practices

  • Advanced investigative and analytical skills

  • Strong negotiation skills

  • Broad understanding of clinical management technology and systems, and strong computer skills

  • Familiarity with the practices, processes, and requirements of clinical trials

  • Strong judgment, decision making, escalation, and risk management skills

  • Effective oral and written communication skills including the ability to communicate in English, both orally and in writing

  • Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting

  • Great attention to detail

  • Broad understanding of regulatory guidelines and directives

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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