Regulatory Affairs Clinical Scientist

Posting Date 8 months ago(1/25/2021 12:01 PM)
Requisition ID
2021-8449
Job Location(s)
Pittsburgh PA United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Regulatory Affairs

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 will lead scientific evaluation and writing of regulatory clinical submissions of the company, including common technical documents and researches various scientific and medical topics related to the technology and company product lines.

Responsibilities

• Lend scientific advice to the planning, undertaking and oversight of product trials and regulatory inspections

• Assist in managing 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

• Anticipate regulatory consequences; develop and maintain knowledge of clinical trial and its associated history and product lines to assess the consequences of regulatory changes for the product

• Ensure 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

• Plan and assist with formal meetings and teleconferences with regulatory authorities

• Review documentation from other departments that may affect regulatory submissions

• Ensure that any proposed changes to documentation are consistent with applicable regulatory requirements and that they do not affect a regulatory submission or require communication to regulatory authorities

• Provide interpretive analyses of complex regulatory guidance documents, regulation, or directives that impact products

• Compile and submit annual report and post-approval supplements for products

• Maintain schedule of and file post-approval documentation

• Assist in reviewing clinical trial documentation, protocol, informed consent forms, ICFs, etc. for regulatory impact, when necessary

Qualifications

• Undergraduate degree in any Life Sciences, or 2-4 years of direct, relevant experience in Regulatory Affairs to provide a comparable background

• Minimum of 2-4 years of experience in Regulatory Affairs or GMP/GCP setting preferred

• Graduate degree in any Life Sciences, Regulatory, or related discipline preferred

• Knowledge of clinical trial regulations and guidelines governing biological product development required

• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices

• Advanced proficiency in MS Office, specifically, advanced knowledge of Adobe, OneNote, Excel, Word and PowerPoint

• Must work and interact effectively and professionally with others
• Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision

 

Physical Requirements:

• Office Setting (with limited travel): General office, warehouse and laboratory setting.

• Travel required up to 10%, including domestic and international travel. 

• 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.

 

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