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 Senior Medical Writer is a key individual responsible for writing, reviewing, and editing clinical documents. This is an individual contributor position with team leadership responsibilities. The senior medical writer will work closely with cross-functional teams to ensure the documents are high quality and completed in a timely fashion and in compliance with ICH/GCP/regulatory guidelines, SOPs, and company goals. This individual may also support other medical writing activities as requested.
Responsibilities
- Write, review, and edit clinical regulatory documents such as clinical study protocols,
- CSRs, Investigator’s Brochures, IND/NDA/BLA clinical summaries, and other documents as required for submissions
- Interpret statistical and clinical data with appropriate guidance/direction from teams and management
- Arrange and conduct review meetings with teams and independently resolve document content issues and questions arising from the writing/review process
- Work with cross-functional groups, including clinical research, biostatistics and drug safety, to set priorities for document preparation and collaborate on document content.
- Represent Medical Writing on project teams and advise on content and format requirements for various documents
- Develop timelines and communicate writing process and timelines to team members
- Interact with internal and external authors (as needed) and key stakeholders to develop high quality documents
- Provide status/updates of Medical Writing deliverables to management, and create/track timelines
- Contribute to document templates (e.g., protocols, CSRs) and style guides
- Comply with established company policies and procedures, and industry and regulatory guidelines
- May contribute content to safety documents (e.g., DSURs)
- Assist in the development of SOPs for Medical Writing processes
- Provide additional support to the Medical Writing team and the Clinical and Regulatory team as needed
- Other duties as assigned
Qualifications
- BA/BS in one of the life sciences with a minimum of 5 years of scientific or medical writing experience at a biotech/pharmaceutical company; or MA/MS/PhD with 4+ years of relevant medical writing experience
- Ability to work both independently and in cross-functional team environments with minimal supervision.
- Ability to work effectively in a fast-paced environment with multiple high-priority projects
- Project management skills
- Knowledge of regulatory guidelines (e.g., ICH) and Good Clinical Practices (GCP)
- Strong written and verbal communication skills. Ability to engage and disseminate information among appropriate stakeholders for effective document production.
- Attention to detail with an ability to detect errors and inconsistencies in various types of documents
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.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
