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Director of Medical Writing

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: Akebia Therapeutics Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

The Senior Director, Medical Writing, is responsible fordeveloping and leading a centralized Medical Writing function thatis responsible for the writing, editing, and completion of Akebiadocuments required to support regulatory submissions.

The Senior Director, Medical Writing must ensure that qualitysystems and processes are in place to support the review andcompletion of documents and ensure appropriate document templatesare in place for documents such as, but not limited to, ClinicalStudy Reports, Protocols and Investigator Brochures and otherdocuments necessary for regulatory submissions. This position mustensure appropriate planning and orchestration of medical writingactivities across multiple functions for the completion of highquality, submission ready documents on time in support of Akebia’sregulatory submissions.

The Sr. Director, Medical Writing is accountable forcoordination of all aspects of medical writing for Akebia,including vendor selection and management, resource planning andexecution across all areas requiring medical writing support. TheSr. Director, Medical Writing, provides leadership, guidance,medical writing expertise and direction to both Akebia staff aswell as vendors and/or independent consultants responsible for thecompletion of submission ready documents.

The Sr. Director of Medical Writing will ensure sufficient staffand resources in place to complete all documents of the highestquality necessary to support the regulatory submissions worldwidethat adequately represent safety and effectiveness of Akebia’sproducts.

This position will report to the VP of Clinical Operations.

Required Skills Accountable for the identification and selectionof qualified vendor(s) or consultants as required to prepare,write, edit, and review clinical and regulatory documents incollaboration with the project teams.

Collaborate with Akebia senior management staff within Medical,Clinical, Regulatory and other areas in scope to appropriatelyforecast writing needs and ensure appropriate resources aresecured.

Ensure appropriately trained and experienced medical writersrelative to documents being prepared, are aligned and available foron time completion and approval of documents as forecasted to meetregulatory timeline commitments

Direct internal staff or staff of vendor writers and/orconsultants to ensure all Akebia medical writing needs in scope arecompleted on time and with quality.

Set standards for process of document review, completion andapproval and ensure adherence in order to meet establishedtimelines. This may include management of established governanceapproval(s) of in scope documents such as protocols, clinical studyreports etc.

Ensure selection and utilization of standard document templatesfor selected document types. Ensure appropriate version control anddocument warehouse is utilized as needed.

Establishes standard quality control (QC) system of review ofvarious regulatory and medical documents and oversees management ofthe process.

Ensure development and maintenance of SOPs that documentrequirements for completion of regulatory submission readydocuments and associated writing tools such as templates and styleguides.

Develops and maintains Akebia master document list and timelinesin collaboration with senior management and function leads.

Ensures proper training of staff and/or vendor on medicalwriting templates, SOPs, and processes within the department andacross departments.

Ensures identification and selection of electronic documentsystems and tools necessary for document review, approval andarchival.

Provides guidance as needed on clinical data being consideredfor presentation and/or publications to ensure alignment withscientific strategies and corporate goals.

Serves as subject matter expert in writing, coordination,management and completion of submission ready documents andprovides guidance to project team(s) as required.

Required Experience Basic Qualifications:

Bachelor’s degree and a minimum of 15 years biopharmaceuticalindustry experience.

5 years’ experience in managing staff of medical writers and/orvendors in preparation of technical documents (e.g., CMC,nonclinical, clinical, regulatory, etc.) including publishing andsubmissions.

Preferred Qualifications:

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 multipleprojects in a fast-paced environment.

Ability to understand and interpret clinical trial output;summarize complex results and present them in a clear, concise, andscientifically 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 integratedbiopharmaceutical company focused on the development andcommercialization of therapeutics for people living with kidneydisease. The Company was founded in 2007 and is headquartered inCambridge, Massachusetts. For more information, please visit ourwebsite at www.akebia.com

Akebia Therapeutics is an equal opportunity employer andwelcomes all job applicants. All qualified applicants will receiveconsideration for employment without discrimination on the basis ofrace, color, religion, sex, sexual orientation, gender identity,national origin, protected veteran status, disability, or any otherfactors prohibited by law.

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Akebia for any position postedon our career page must have a current Akebia agency agreementexecuted by a member of the Human Resource Department. In addition,agencies may only submit candidates to positions for which theyhave been invited to do so by an Akebia Recruiter. All resumessubmitted outside of these terms will not be considered

Keywords: Akebia Therapeutics Inc., Cambridge , Senior Director Medical Writing, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Director of Medical Writing, Other , Cambridge, Massachusetts

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