Contract - CMC Documentation Specialist
Contract - CMC Documentation Specialist
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$ 34 - 56
1 Vacancy
Job Description
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:
Bachelors 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.
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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 candidates 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 ourGeneral Data Protection Regulation (GDPR) policyPRIOR 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 () 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
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If you are unsure about the authenticity of an offer or if you receive any suspicious communication please contact us directly at
Cytokinetics is an Equal Opportunity Employer
Required Experience:
Unclear Seniority
Employment Type
Full-Time
