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Director, Senior Director Medical Writing

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

Job Description:

Director, Senior Director Medical Writing Company: HCPro, Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Director, Senior Director Medical Writing

Director, Senior Director Medical Writing Cambridge,Massachusetts, United States

30+ days ago

Description

The Director/Senior Director of Medical Writing is responsiblefor leading a centralized technical writing organization, whilecontinuing to assess the writing needs across the R&Dorganization to support clinical regulatory submissions.

The Director/Senior Director, Medical Writing must ensure thatquality systems and processes are in place to support the author,review, and approval of documents and ensure appropriate templatesare in place for documents such as, but not limited to, ClinicalStudy Reports, Protocols and Investigator Brochures and otherdocuments necessary for clinical regulatory submissions. Thisposition must facilitate the planning and coordination of writingactivities across R&D, including clinical development, clinicaloperations, regulatory, pharmacovigilance, pharmacology,biostatistics and CMC, for the completion of quality, submissionready documents in support of Sumitomo Dainippon Pharma Oncology,Inc regulatory submissions.

The Director/Sr. Director, Medical Writing is accountable forcoordination of all aspects of technical writing, including vendorselection and management, resource planning and execution acrossall areas requiring writing support. The Director/Sr. Director,Medical Writing provides leadership, guidance, medical writingexpertise and direction to both R&D staff as well as vendorsand independent consultants responsible for the completion ofsubmission ready documents.

Responsibilities

Leads, directs, and mentors the medical writing team

Accountable for the identification, selection and oversight ofqualified vendor(s) or consultants as required to prepare, write,edit, and review clinical and regulatory documents in collaborationwith the clinical development teams.

Ensure development and maintenance of SOPs related to thedevelopment of clinical regulatory documents.

Establish writing standards that include document templates andstyle guides compliant with regulatory agencies and writingstandards in collaboration with clinical development teams.

Establish medical writing timelines and forecast writing needsand ensure appropriate resources.

Set standards for process of document review, completion andapproval, ensure adherence to regulatory requirements, standards,and consistent with America Medical Writing Standards or otherwriting standards, where applicable.

Establish standard quality control (QC) system of review forclinical regulatory documents and oversees management of theprocess.

Ensure proper training of staff and/or vendor on medical writingtemplates, SOPs, and processes including use of electronic documentsystem within the department and across departments.

Perform other duties as assigned.

Qualifications

Bachelor’s degree in a life sciences discipline required and aminimum 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 ofexperience in managing staff of medical writers and/or vendors inpreparation of technical documents (e.g., CMC, nonclinical,clinical, regulatory, etc.) including publishing andsubmissions.

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 softwarepreferred.

Experience in coordination and prioritization of multipleprojects in a fast-paced environment.

Must have proven ability to understand and interpret clinicaltrial output; summarize complex results and present them in aclear, concise, and scientifically accurate manner to various endusers.

Background in oncology drug development is preferred.

Fluent in English (oral and written)

Please send resumes totalentacquisition@bostonbiomedical.com

Equal Opportunity Employer

California residents, please visitwww.bostonbiomedical.com/CAprivacynotice for information on ourprivacy practices.

Job Information

Job ID: 53749185

Location:

Cambridge, Massachusetts, United States

Position Title: Director, Senior Director Medical Writing

Sumitomo Dainippon Pharma Oncology, Inc. is a developer of novelcancer therapeutics based in the U.S. and a wholly owned subsidiaryof Sumitomo Dainippon Pharma Co., Ltd. This U.S. entity, togetherwith the oncology research and development teams in Japan, DSPCancer Institute and Oncology Clinical Development Unit, willcollectively be known as Sumitomo Dainippon Pharma Oncology or SDPOncology. SDP Oncology is relentlessly committed to advancingpurposeful science by transforming new discoveries into meaningfultrea...

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

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