Job Details

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

The Document Specialist/Coordinator will be responsible for authoring, managing, and coordinating the documentation related to Chemistry, Manufacturing, and Controls (CMC), Technical Operations, and Manufacturing activities within the Global Supply Chain and Technical Operations organization. This role involves supporting the CMC, Technical Operations, and Manufacturing functions as needed in supporting compliance with quality and regulatory requirements.

Key Responsibilities:

• Organize, maintain, and archive CMC, Technical Operations, and Manufacturing documentation.
  
• Ensure all CMC, Technical Operations, and Manufacturing documentation complies with regulatory and quality guidelines (e.g., FDA, EMA) and company standards.
  
• Collaborate with cross-functional teams (e.g., Quality Assurance, Regulatory Affairs, Global Supply Chain) to gather necessary information and ensure timely completion of CMC documents.
  
• Assist in the preparation of CMC sections of regulatory filings, including INDs, IMPDs, NDAs, and MAAs.
  
• Work with CMC, Technical Operations, and Manufacturing SMEs to ensure documents are accurate, complete and consistent.
  
• Open and coordinate change controls/deviations in QMS.
  
• Provide support to CMC team members on document management systems.
  
• Support internal and external audits and inspections by ensuring availability and integrity of CMC documentation.
  
• Identify opportunities for process improvements in document management and implement best practices.
  

Qualifications:

• Bachelor's degree in Life Sciences (preferably Chemistry), or a related field. Advanced degree preferred.
  
• Minimum of 3 years of experience in CMC documentation within the pharmaceutical industry.
  
• Strong understanding of regulatory requirements for CMC documentation (e.g., FDA, EMA guidelines).
  
• Excellent organizational, communication, and interpersonal skills.
  
• Proficiency and experience with document management systems (i.e. Veeva, Box, and SharePoint) and Microsoft Office Suite.
  
• Working knowledge of change controls, deviation investigations, and GMP requirements.
  
• Excellent attention to detail, organizational, and communication skills.
  
• Ability to work independently and as part of a cross-functional team under tight deadlines.
  
• Working knowledge of ICH guidelines and regulatory writing best practices.
  
• Good technical writing skills.
  

Pay Range:

In the U.S., the hiring pay range for fully qualified candidates is $34-$56 per hour. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

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 ...@cytokinetics.com
  

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer