Senior Director Medical Writing
The Senior Director, Medical Writing, is responsible for developing and leading a centralized Medical Writing function that is responsible for the writing, editing, and completion of Akebia documents required to support regulatory submissions.
The Senior Director, Medical Writing must ensure that quality systems and processes are in place to support the review and completion of documents and ensure appropriate document templates are in place for documents such as, but not limited to, Clinical Study Reports, Protocols and Investigator Brochures and other documents necessary for regulatory submissions. This position must ensure appropriate planning and orchestration of medical writing activities across multiple functions for the completion of high quality, submission ready documents on time in support of Akebia’s regulatory submissions.
The Sr. Director, Medical Writing is accountable for coordination of all aspects of medical writing for Akebia, including vendor selection and management, resource planning and execution across all areas requiring medical writing support. The Sr. Director, Medical Writing, provides leadership, guidance, medical writing expertise and direction to both Akebia staff as well as vendors and/or independent consultants responsible for the completion of submission ready documents.
The Sr. Director of Medical Writing will ensure sufficient staff and resources in place to complete all documents of the highest quality necessary to support the regulatory submissions worldwide that adequately represent safety and effectiveness of Akebia’s products.
This position will report to the VP of Clinical Operations.
- Accountable for the identification and selection of qualified vendor(s) or consultants as required to prepare, write, edit, and review clinical and regulatory documents in collaboration with the project teams.
- Collaborate with Akebia senior management staff within Medical, Clinical, Regulatory and other areas in scope to appropriately forecast writing needs and ensure appropriate resources are secured.
- Ensure appropriately trained and experienced medical writers relative to documents being prepared, are aligned and available for on time completion and approval of documents as forecasted to meet regulatory timeline commitments
- Direct internal staff or staff of vendor writers and/or consultants to ensure all Akebia medical writing needs in scope are completed on time and with quality.
- Set standards for process of document review, completion and approval and ensure adherence in order to meet established timelines. This may include management of established governance approval(s) of in scope documents such as protocols, clinical study reports etc.
- Ensure selection and utilization of standard document templates for selected document types. Ensure appropriate version control and document warehouse is utilized as needed.
- Establishes standard quality control (QC) system of review of various regulatory and medical documents and oversees management of the process.
- Ensure development and maintenance of SOPs that document requirements for completion of regulatory submission ready documents and associated writing tools such as templates and style guides.
- Develops and maintains Akebia master document list and timelines in collaboration with senior management and function leads.
- Ensures proper training of staff and/or vendor on medical writing templates, SOPs, and processes within the department and across departments.
- Ensures identification and selection of electronic document systems and tools necessary for document review, approval and archival.
- Provides guidance as needed on clinical data being considered for presentation and/or publications to ensure alignment with scientific strategies and corporate goals.
- Serves as subject matter expert in writing, coordination, management and completion of submission ready documents and provides guidance to project team(s) as required.
- Bachelor’s degree and a minimum of 15 years biopharmaceutical industry experience.
- 5 years’ experience in managing staff of medical writers and/or vendors in preparation of technical documents (e.g., CMC, nonclinical, clinical, regulatory, etc.) including publishing and submissions.
- Prior NDA/BLA/MAA submission experience, including eCTD.
- Bachelor’s degree in a life sciences discipline
- Masters/PhD degree in a life sciences discipline
- Strong knowledge of FDA/ICH guidelines and GCP.
- Strong written and verbal communication skills.
- Expert abilities in Microsoft Word office.
- Experience with Adobe Acrobat and Medical writing software.
- Experience in coordination and prioritization of multiple projects in a fast-paced environment.
- Ability to understand and interpret clinical trial output; summarize complex results and present them in a clear, concise, and scientifically accurate manner to various end users.
- Background in anemia, CKD, or oncology drug development.
- Fluent in English (oral and written).
Moderate travel (25%) may be required.
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com
Akebia Therapeutics 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.
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