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(Senior) Specialist Regulatory Affairs/Start-Up

2+ years
Not Disclosed
10 Nov. 25, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description:
Ergomed Group is a fast-growing, full-service mid-sized Contract Research Organization (CRO) specializing in Oncology and Rare Diseases. Since its inception in 1997, Ergomed has achieved steady, organic growth through strategic investments and key acquisitions, with operations across Europe, North America, and Asia.

At Ergomed, we foster an international culture where employee voices are heard, creative contributions are valued, and career development is nurtured. We prioritize employee well-being, mental health, and work-life balance, knowing that a healthy environment supports high-quality client service and continuous growth.

Join us on this exciting journey to make a positive impact on patients' lives.

Job Description:
We are seeking a Specialist/Senior Specialist in Study Start-Up and Regulatory to support the completion of study start-up and regulatory deliverables. The role involves coordinating with the SSU/Regulatory Lead to meet site-specific submission timelines, serving as a liaison between regulatory project teams, authorities, vendors, and investigative sites, and ensuring compliance with all applicable regulations.

Key Responsibilities:

  • Support the SSU/Regulatory Lead in meeting site-specific submission and approval timelines. Provide clear rationales for delays and mitigation plans when necessary.
  • Prepare and collect regulatory documents for FDA, EMA, and national authority submissions (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs) as well as for Ethics Committees/IRBs.
  • Review and track essential documents for site initiation and activation, ensuring completeness and compliance.
  • Actively communicate with investigative sites for updates on essential document completion and regulatory/EC approvals.
  • Participate in the development, review, negotiation, and approval of Informed Consent Forms (ICFs).
  • Coordinate with study teams, clinical monitoring, contracts, and other departments to process documents leading to investigational product release and site initiation.
  • Support feasibility studies, site identification, and site-specific document customization (e.g., informed consent).
  • Arrange translation of essential documents when needed.
  • Ensure timely submission of relevant essential documents to the Trial Master File (TMF) in accordance with SOPs and study requirements.

Qualifications:

  • Bachelor’s degree (BA/BS) in a science-related field or equivalent combination of education, training, and experience.
  • Experience in the pharmaceutical, biotechnology, or CRO industry with knowledge of the clinical trial process.
  • Previous experience in Clinical Trial Regulatory submissions.
  • Excellent oral and written communication skills.
  • Strong interpersonal and organizational skills with great attention to detail.
  • Proficient in customer/client relationship management and proactive problem-solving.
  • Knowledge of clinical research principles, methods, and documentation.
  • Strong computer skills (MS Word, Excel, PowerPoint, Outlook).
  • Experience with ICH/GCP documentation and processes is preferred.
  • Ability to manage multiple projects, prioritize effectively, and meet deadlines.

Additional Information:
Ergomed offers excellent opportunities for career growth and development in the clinical drug development field, particularly within oncology, rare diseases, and neurology.

We prioritize diversity, equity, and inclusion, creating an environment where individuals from all cultural backgrounds, genders, and ages can thrive. Our human-first approach drives our continued success, as our people are at the heart of improving the lives of those we serve.

What We Offer:

  • Internal training and career development opportunities.
  • Emphasis on personal and professional growth.
  • A supportive, friendly working environment.
  • Global collaboration with colleagues from all over the world, with English as the company language.

Core Values:

  • Quality
  • Integrity & Trust
  • Drive & Passion
  • Agility & Responsiveness
  • Belonging
  • Collaborative Partnerships

If you resonate with our values and are ready to make a meaningful impact in clinical drug development, we look forward to receiving your application.

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