Job Description
Job Description Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.
At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.
Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.
This is life-changing work, and we are all in, are you?
This role is responsible for clinical and regulatory strategic document expertise across the global marketed and development portfolio. You will support the development of all clinical and regulatory documents to be included in FDA and global health authority (HA) submissions, including initial Investigational New Drug applications, New Drug and Marketing Authorization Applications, information requests, briefing documents, amendments, and pediatric plans. You will collaborate with the Regulatory Strategy Lead and cross-functional teams providing timelines and preparation of documents in support of clinical development, trials, and regulatory filings.
This role is based in Cambridge, MA with the possibility of being a remote role. Applicants must be able to come to office on a regular basis. Reports to VP, Regulatory.
Primary Responsibilities Include: - Demonstrate competence in writing, editing, and reviewing protocols, investigator brochures, registration dossier modules, briefing documents, and other clinical regulatory documents per company and other guidelines.
- Represent medical writing in cross-functional team meetings.
- Apply knowledge of regulatory medical writing and therapeutic area to support pipeline.
- Interpret data and apply knowledge of regulations and guidance to document preparation.
- Develop timelines to support document development.
- Develop, revise, and maintain document templates.
- Participate in improvement of medical writing process.
Basic Qualifications: - Minimum of a BA/BS degree
- PhD preferred
- 5+ years of experience in medical or regulatory writing
Preferred Qualifications: - Able to display excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze. complex issues to develop relevant and realistic regulatory operation strategies.
- Able to demonstrate flexibility and accountability and identify potential issues and mitigate risks.
- Thorough knowledge in Microsoft Office, Adobe Acrobat and SharePoint. Knowledge in authoring Veeva RIM is a plus.
- Experience with document formatting and authoring templates.
- Experience in project management including timeline development.
- Experience with managing consultants and partners.
- Able to proactively support and consult colleagues for guidance and training in business process, and writing standards, as necessary.
- Able to work with strategic deadlines and adapt quickly to changing requirements and priorities.
- Attention to detail.
- Embrace Akebia's core values and culture.
- Excitement about the vision and mission of Akebia.
Compensation: Targeted Base: 131,419 - 162,341*
*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.
Are you an Akebian? An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website:
COVID 19 Vaccination: All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Akebia will consider, among other things whether a proposed accommodation would create an undue hardship. Please note that it is unlikely that accommodations can be granted for customer-facing positions.
Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law. Akebia Therapeutics
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