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Expert Consultant – Contingent Worker

15+ years
Not Disclosed
10 Jan. 3, 2025
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

Job Title: Senior Regulatory Consultant - CP&C
Location: Nationwide (Various Locations)
Company: Labcorp

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Essential Job Duties:

The following duties describe the general nature of the role but are not intended to be an exhaustive list of all responsibilities, skills, and tasks required.

  • Customer Satisfaction & Project Management (30%): Achieve high customer satisfaction by ensuring projects are completed on time, within budget, and with the desired quality for regulatory submission. Responsibilities include peer reviewing documents, writing high-level summaries, conducting complex assessments, preparing position papers, and participating in meetings with regulatory authorities.

  • Regulatory & Scientific Advice (25%): Provide high-level regulatory and scientific guidance to clients, management, and departmental regulatory staff, with a deep understanding of client regulatory strategies and objectives.

  • Business Growth & Client Engagement (15%): Support the growth of the CP&C Regulatory Consultancy & Testing businesses. This involves co-traveling with sales teams on customer visits, participating in client visits to Labcorp sites, leading project design, and providing issue management advice. Also work with marketing to promote CP&C services and contribute to the training and development of team members.

  • Industry Knowledge & Development (10%): Stay updated on new regulatory and scientific developments, communicating these to the regulatory team to help shape the development of the CP&C Regulatory Consultancy and Testing businesses in areas of expertise.

  • External Relationships & Industry Presence (10%): Actively build and maintain relationships with regulatory authorities, industry bodies, and scientific forums. Represent the company at external conferences and meetings to enhance its profile and credibility.

  • Performance & Development (5%): Manage own performance, including timely and accurate recording of hours, achieving billability targets, sourcing work opportunities, managing professional development objectives, and meeting set performance indicators.

  • Process Improvement (5%): Proactively suggest process improvements to systems and infrastructure within CP&C Regulatory to ensure effective and efficient operations.


Experience:

Minimum Required:

  • Significant experience (more than 15 years) in a chemical or biological science-related field, specifically within regulatory testing or consultancy sectors.
  • Established industry profile with strong relationships with regulatory authorities and CP&C customers.

Education:

  • BSc/PhD in a relevant field, or equivalent experience that may substitute for the level of education.

Equal Opportunity Employer Statement:

Labcorp is an Equal Opportunity Employer (EOE/AA). We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on the business needs and qualifications of individuals, and we do not discriminate based on race, religion, color, national origin, gender (including pregnancy or medical conditions), family or parental status, marital status, sexual orientation, gender identity, gender expression, age, veteran status, disability, or any other protected status.

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