Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Good Clinical Practices (GCP) Project Management Methods Engineering Process Management Software Documentation Vendor Management Risk Management Risk Analysis Drug Development Change Management Stakeholder Communications Internal Documentation

Other Skills

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Microsoft Word
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Microsoft Excel
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Virtual Teams
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Communication
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Teamwork
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Analytical Thinking
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Detail Oriented

Roles & Responsibilities

BS/BA degree with 5+ years of pharmaceutical/biotech experience
GCP experience (5+ years) and strong knowledge of drug development processes
Experience in process management, project management, and SOP writing; demonstrated project management and implementation techniques
Proficiency in Microsoft Office applications (Word, Excel, TEAMS)

Requirements:

Develop SOP mapping between sponsor SOPs and the acquiree's sponsor/CRO/vendor procedural documentation
Conduct comparison assessments of procedural documentation to identify major gaps and validate with the business process owner and SOP authors
Facilitate risk assessments of gaps and document interim procedures to mitigate risk
Develop the official transition communication using templates and develop the retirement strategy

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

JOB RESPONSIBILITIES

Developing SOP mapping between sponsor SOPs and the aquiree’s sponsor/contract research organization (CRO)/vendor procedural documentation
Conduct comparison assessments between the procedural documentation to identify major gaps and work with the business process owner and SOP authors to validate
Facilitate the risk assessment of gaps with the business and document any interim procedures to mitigate the risk
Develop the official transition communication (using templates)
Develop the retirement strategy

ORGANIZATIONAL RELATIONSHIPS

Head of SOPs
SOP Acquisition Lead
Business Process Owners (BPOs) for clinical, medical, safety, regulatory and quality management system process areas
SOP Authors for clinical, medical, safety, regulatory and quality management system process areas
Quality organization colleagues
Sourcing Risk & Compliance
Project Management Office (PMO) Colleagues (PMOs are established per business deal)

QUALIFICATIONS / SKILLS

BS/BA Degree plus 5+ years Pharma experience.
GCP experience (5 years); process management, project management, SOP writing.
Demonstrated experience in project management and implementation techniques.
GCP experience and a strong working knowledge and understanding of drug development processes.
Required: Proficient in Microsoft applications (i.e., Word, Excel, TEAMS)