Senior Medical Writer
Location: Cambridge, MA (Remote possibility)
Regulatory Affairs
At Akebia, we are dedicated to bettering the lives of those impacted by Chronic Kidney Disease. Our passionate employees challenge the status quo and work to develop unique therapeutics that set new standards of care.
This role is responsible for clinical and regulatory strategic document expertise across our global marketed and development portfolio. You will support the development of all clinical and regulatory documents for FDA and global health authority submissions, including Investigational New Drug applications, New Drug Applications, and Marketing Authorization Applications. You will collaborate with cross-functional teams to provide timelines and prepare documents supporting clinical development and regulatory filings.
Primary Responsibilities Include:
- Demonstrate competence in writing, editing, and reviewing clinical regulatory documents.
- Represent medical writing in cross-functional team meetings.
- Apply knowledge of regulatory medical writing and therapeutic areas to support the pipeline.
- Interpret data and apply knowledge of regulations to document preparation.
- Develop timelines to support document development.
- Develop, revise, and maintain document templates.
- Participate in the improvement of the medical writing process.
Basic Qualifications:
- Minimum of a BA/BS degree
- PhD preferred
- 5+ years of experience in medical or regulatory writing
Preferred Qualifications:
- Excellent interpersonal skills and ability to develop relationships with stakeholders.
- Flexibility and accountability in identifying potential issues and mitigating risks.
- Thorough knowledge of Microsoft Office, Adobe Acrobat, and SharePoint; knowledge of Veeva RIM is a plus.
- Experience with document formatting and authoring templates.
- Experience in project management including timeline development.
- Experience managing consultants and partners.
- Ability to support and consult colleagues on business processes and writing standards.
- Ability to work with strategic deadlines and adapt to changing requirements.
- Attention to detail.
- Excitement about Akebia's vision and mission.
Compensation:
Targeted Base: 131,419 - 162,341*
*Base compensation will depend on factors including qualifications, skills, and experience. All regular employees are eligible for the corporate bonus program and additional benefits such as health care, vision, dental, retirement, and PTO.
COVID-19 Vaccination: All new hires will be required to provide documentation of full COVID-19 vaccination or request an accommodation.
Akebia is an equal opportunity employer and welcomes all job applicants without discrimination.
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