JOB DESCRIPTION

With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications.

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 8+ years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.

REQUIREMENTS

The ideal candidate will possess the following qualifications:

Project management skills, Pharma industry recommended, Submission Management background required. Position supporting of Canada Submissions ECTD. Background in CA submission preferred.

What are the top 5 skills/requirements this person is required have?
a. Required Skill 1: Pharmaceutical/Industry experience
b. Required Skill 2: Project Management
c. Required Skill 3: Leadership skills
d. Required Skill 4: Meeting Facilitation

What years of experience, education, and/or certification is required? 4 years experience in Pharma, Bachelor’s degree

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Regulatory Operations, including Submission management. Experience with Canada regulations for pharmaceutical and device products

Job Type: Contract

Pay: $48.00 - $50.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

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

Application Question(s):

• Do you have any experience working with submission management functions on a project management team?
• Any experience working in the pharmaceutical industry?

Work Location: One location

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