Sr Group Leader (Pharma)

5+ years

Not Disclosed

Remote

10 Dec. 11, 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

Job Title: Senior Group Leader – Pharma
Company: Thermo Fisher Scientific
Location: Not specified
Work Schedule: Other
Environmental Conditions: Office environment

Job Description:
At Thermo Fisher Scientific, you’ll have the opportunity to make a positive impact globally by joining our mission to enable customers to create a healthier, cleaner, and safer world. With a strong investment in R&D, clinical trials in over 100 countries, and cutting-edge frameworks for clinical research, we provide the resources needed to support innovative and life-changing therapies.

Location/Division Specific Information:
Our PPD® Laboratory Services team drives patient health improvement through the expertise of scientists and industry thought leaders. Join our team, where we lead with accuracy, quality, and innovation, providing groundbreaking solutions to clinical research challenges.

Key Responsibilities:

Manage a tiered organizational structure including supervisors and analysts.
Allocate and manage laboratory resources for project activities; update LIMS for project status and review timesheet reports for billing accuracy.
Review and approve study protocols, project status reports, and final study reports.
Oversee the technical quality of data, ensuring compliance with protocols, methods, and SOPs.
Approve laboratory investigations, deviations, and QA facility audits. Lead client and regulatory authority audits.
Respond to client inquiries, lead technical meetings, and provide recommendations on analytical and compliance issues.
Prepare and approve project proposals, pricing, and timelines. Participate in project definition and client negotiations.
Prepare and implement SOPs and operational policies, ensuring adherence and recommending quality improvements.
Collaborate with business development to identify business opportunities and represent the company during client visits and conferences.
Participate in technical sales and marketing initiatives and the bi-annual SOP review process.
Regularly communicate quality-related issues and staff development items, implementing quality improvements.

Education and Experience:

Bachelor’s degree in a relevant field (e.g., chemistry, pharmaceutical science).
8+ years of experience or an equivalent combination of education and relevant experience.
2+ years of management responsibility.
Proven track record in pharmaceutical, biotech, or analytical contract laboratory industries.

Skills and Abilities:

Management experience in pharmaceutical/biotech/analytical contract laboratory industries.
Strong knowledge of GMP requirements, client SOPs, ICH guidelines, and FDA/EMA regulations.
Experience with techniques like HPLC, UPLC, KF, UV-Vis, and others.
Understanding of basic financial terms related to business operations.
Ability to independently develop project proposals and plans, ensuring client needs are met.
Excellent communication and leadership skills, with the ability to cultivate collaborative working environments.

Work Environment:

Ability to communicate effectively with diverse groups of people.
Capability to work upright and stationary for typical working hours and lift up to 15-20 pounds.
Ability to work in non-traditional work environments and handle multiple projects under pressure.
May encounter potentially hazardous elements in healthcare or laboratory settings.

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Sr Group Leader (Pharma)

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