Regulatory Affairs Clinical Scientist

Posting Date 2 months ago(10/17/2022 9:55 AM)
Requisition ID
2022-11742
Job Location(s)
Pittsburgh PA United States
Travel
10-20%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Clinical

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The Regulatory Affairs Clinical Scientist at Cook MyoSite, Inc. will contribute to the Clinical Science department through direct support of clinical development pipeline. Guide scientific evaluation and writing in support of high quality clinical regulatory submissions of the company, including common technical documents, INDs, pre- and post-market authorizations.

Responsibilities

• Lend scientific advice to the planning, undertaking and oversight of product trials and regulatory inspections
• Assist in interpreting, positioning, and authoring the regulatory aspects of projects/products, including major, complex applications submitted to regulatory agencies
• Assist in preparing clinical documents for regulatory submissions, including clinical study reports, clinical protocols, investigator’s brochures, and safety and efficacy summaries
• Conduct research and regulatory intelligence on submission requirements and options (regulations, guidance, precedence)
• Develop and maintain knowledge of clinical trial and its associated history and product lines to assess the consequences of regulatory changes for the product
• Participate in the preparation and review of study-related documents, plans, training materials, and regulatory updates
• Assist in ensuring that regulatory submissions are complete, accurate, and comply with applicable regulatory requirements
• Assist in setting up direct interactions with governmental agencies and personnel, including scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications
• Support formal meetings and teleconferences with regulatory authorities
• Create and/or maintain submission authoring templates
• Participate in the writing and reviewing of clinical regulatory processes (BOP, Work Instructions and internal guidelines)
• Assess proposed changes to documentation to ensure consistency with applicable regulatory requirements and need for communication to regulatory authorities
• Provide interpretive analyses of complex regulatory guidance documents, regulation, or directives that impact products and operations
• Assist in reviewing clinical trial documentation, protocol, informed consent forms, ICFs, etc. for regulatory impact, when necessary

Qualifications

• Undergraduate degree in Life Sciences, Engineering or any related field or 3+ years’ direct, relevant experience in pharmaceutical/biotech/regulatory affairs to provide a comparable background

• Graduate degree in Life Sciences or Engineering field is preferred
• Minimum of 2 years' experience in pharmaceutical industry in new drug regulated product strategy and submissions, including working knowledge of FDA regulations and guidance for new drugs and biologics

• Advanced degree in Life Sciences or Engineering is preferred
• Regulatory Affairs Certification (RAC) is preferred
• Experience in Common Technical Document (CTD) or medical writing is preferred
• Experience in global clinical trial regulations and guidelines governing biological product development is preferred

• Proficient knowledge of Microsoft Office software, and other general office equipment.
• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices

 

Physical Requirements:

• Full time remote position | Flexible work environment

• Setting (Remote/Field Based): General office or home office setting

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.
• Must be (a) physically capable of operating a motor vehicle on a regular basis, (b) a holder of a valid driver's license, and (c) in good standing to legally operate a motor vehicle.
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.
• Must be able to lift/push/pull up to 25 pounds on an occasional basis with or without reasonable accommodations.

 

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