Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
We are seeking a highly motivated Intern to join our Regulatory Affairs group at Cytokinetics.
Job Description:
The Regulatory Operations internship is designed to give students hands-on insights and working experience of several regulatory operations and affairs functions including Regulatory Systems, Regulatory Project Management, Regulatory Publishing, and Regulatory Strategy. Interns will work closely with these functions to support ongoing regulatory submissions to global health authorities, as well as department projects that support process initiatives.
Systems
- Support day-to-day user management of Cytokinetics regulatory document management system, Veeva RIM
- Learn various features of Veeva RIM
- Sit in on project meetings for rollout of new configurations
Project Management
- Assist with building and managing a submission content plan in Veeva RIM
- Support planning and coordination various documents for submissions to global health authorities.
Publishing
- Gain insight into the publishing process such as document formatting/linking, validation, and transmission of submission to the global health authorities.
- Learn how to eQC (electronic Quality Check) a regulatory submission
Strategy
- Read various health authority questions and responses
- Shadow a regulatory affairs strategist to gain insights
Requirements:
The position requires a motivated individual with the ability to work independently and in a team environment. Additionally, we seek an individual with:
- Pursuing BS degree in Life Sciences (e.g. Biology, Chemistry) or Business
- Proficiency with Microsoft Word, Adobe Professional, and other information technology systems are highly desirable.
- Familiarity with FDA regulatory requirements (e.g., IND, NDA, orphan drug designation).
- Strong attention to detail and ability to manage tasks within defined deadlines
- Demonstrated basic project management skills
- Excellent communication skills and the ability to troubleshoot problems with team members
- Ability to be on site in our Radnor, PA office
Now is the perfect time for you to consider an Internship at Cytokinetics where you can put all of your skills to maximum use. When applying, please provide your spring break and summer availability.
Cytokinetics is an Equal Opportunity Employer
Pay Range:
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
- We do not conduct job interviews through non-standard text messaging applications
- We will never request personal information such as banking details until after an official offer has been accepted and verified
- We will never request that you purchase equipment or other items when interviewing or hiring
- If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com
