The Head of Medical Writing is responsible for leading a centralized technical writing organization spanning writing and publishing needs across the various development functions to support regulatory submissions.
The Senior Director, Medical Writing must ensure that quality systems and processes are in place to support the author, review, and approval of documents and ensure appropriate 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 writing activities across multiple functions, including nonclinical and CMC, 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 technical writing for Akebia, including vendor selection and management, resource planning and execution across all areas requiring 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 are 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, selection and oversight of qualified vendor(s) or consultants as required to prepare, write, edit, and review clinical and regulatory documents in collaboration with the project teams.
Ensure development and maintenance of SOPs that document requirements for completion of regulatory submission ready documents
Establish Akebia writing standards that include document templates and style guides compliant with regulatory agencies and writing standards in collaboration with subject matter experts and Senior Akebia management.
Collaborate with Akebia senior management staff within Medical, Clinical, Nonclinical, CMC, and Regulatory and other areas in scope to appropriately forecast writing needs and ensure appropriate resources are secured.
Ensure appropriately trained and experienced medical writers are in place to draft, edit, and finalize documents as needed for specific programs and regulatory commitments
Direct internal or contracted staff 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, ensure adherence to regulatory requirements, standards, and consistent with America Medical Writing Standards or other writing standards, where applicable.
Establish standard quality control (QC) system of review of various regulatory and medical documents and oversees management of the process.
Ensure proper training of staff and/or vendor on medical writing templates, SOPs, and processes including use of electronic document system within the department and across departments.
Ensure identification and selection of electronic document systems and tools necessary for document review, approval and archiving.
Provide guidance as needed on clinical data being considered for presentation and/or publications to ensure alignment with scientific strategies and corporate goals.
Serve 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 in a life sciences discipline required and a minimum of 15 years biopharmaceutical industry experience. Masters/PhD degree in a life sciences discipline preferred.
Must have at least 10 years in technical writing with 5 years of 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, is required.
Strong knowledge of FDA/ICH guidelines and GCP.
Strong written and verbal communication skills.
Expert abilities in Microsoft Word, Excel, and PowerPoint;
Experience with Adobe Acrobat and Medical writing software preferred.
Experience in coordination and prioritization of multiple projects in a fast-paced environment.
Must have proven 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 is a plus
Fluent in English (oral and written