Job description

Location: Lake County, IL - Hybrid - Onsite required 3 days per week

Contract: 6 months - possible extension

Individual is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will also ensure proper communication with all key partners in the functional departments in support of regulatory filings.

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
• Required Experience: 4 years pharmaceutical . 1-2 years cross functional project management
• Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)
• Superior oral and written communication skills
• Ability to work cooperatively with all levels and types of global personnel required
• Experience working with electronic document management systems
• Ability to work independently under pressure and manage multiple projects simultaneously
• Detail/accuracy oriented
• Collaborative and willing to learn
• Familiarity with US and other international regulatory requirements for drug product dossiers
• Manage, compile, and author CMC sections of marketed product variations with minimal management oversight.
• Update simple CMC documents independently.
• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
• Independently run reviews meetings.
• Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.
• Timely communication of systems issues to management.
• Manages/directs the activities and people associated with small to large scale projects with a focus on any or several non-IT business applications and disciplines.
• Manage/direct all facets of single or multiple, multidimensional, mission-critical projects through the Full Project Life Cycle.
• Collaborate/work with project sponsors, business units and users to identify project scope and focus, develop or monitor project initiatives, implement project requirements/plans/processes/tools, assign/guide/monitor project staff, and assure project success.
• Deliver quality project solutions to business problems or issues within defined budgets and/or timelines.
• Provide expert project guidance/support proactively through project completion.
• Provide tracking, reporting, and presentation to management and users.
• 1-6 years’ experience

Intake Notes

What hours and days will this person be working: 8-5 CST – but will be working with global partners and will need to adjust as needed

Does this position offer the ability to work remotely on a regular basis or is it an on-site role: Hybrid – 3 day per week – local to Lake County, IL

What are the top 5 skills/requirements this person is required have?

• Required Skill 1: Advanced Time Management / Organization Skills
• Required Skill 2: Superior oral and written communication skills.
• Required Skill 3: Ability to work cooperatively with all levels and types of global personnel required.
• Required Skill 4: Experience working with electronic document management systems.
• Required Skill 5: Familiarity with US and other international regulatory requirements for drug product dossiers.
• Required Skill 6: Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.

What years of experience, education, and/or certification is required? BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline - 4 years pharmaceutical . 1-2 years cross functional project management

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)

What is the environment that this person will be working in (i.e. group setting vs individual role)? Individual tasks but within a group setting

Is any testing required for this role? No

Other notable details about the environment from the hiring manager about this role

What positions/background experience do you feel are successful in this role :Quick learner – takes accountability to seek out information to ensure they are successful in the role. Self-motivated.

Job Type: Contract

Salary: $35.00 - $43.00 per hour

Benefits:

• 401(k)

Schedule:

• 8 hour shift
• Monday to Friday
• Overtime

Ability to commute/relocate:

• North Chicago, IL 60064: Reliably commute or planning to relocate before starting work (Required)

Experience:

• FDA regulations: 4 years (Required)
• CMC: 4 years (Required)
• Regulatory Affairs: 4 years (Required)

Work Location: One location

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