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Medical Writing Specialist - Bayer HealthCare Pharmaceuticals
Sep 19
Location: Pine Brook , NJCategories: Pharmaceutical
Website: http://www.bayerjobs.com
Position Description
At Bayer HealthCare Pharmaceuticals we take pride in knowing that our work is an affirmation of life. It stems from our commitment to advance patient care and to shape the future of medicine. It also connects us to the many lives we serve in the Women’s Healthcare, Oncology, Diagnostic Imaging, and Neurology markets. We are a global research-based pharmaceutical company and our purpose is to bring diagnostic and therapeutic innovations to the healthcare community. With a vast global network and a robust product pipeline and U.S. revenues exceeding $2.6 billion, we offer the opportunity for career fulfillment and the chance to make life the best it can be.
The Medical Writing Specialist reports to the regional Medical Writing Manager of the Global Medical Writing function and is responsible for the the tracking, quality control and timely completion of the document components for these complex medical writing projects Concentrate on clinical study report appendices and technical tasks, such as document scanning, formatting and manipulating file types to work with electronic submission publishing software. These projects include Medical Research Reports (CSR’s), protocols, brief CSR’s, and Regulatory Submissions.
1. Work together with key interface partners (e.g. Study Management, Statistics and Programming), to facilitate the completion of clinical study reports and their appendices.Uses project management skills to track, review and ensure timely completion of high quality CSRs
2. Manages the medical writing project tracking database, as directed by the Medical Writing Manager, to ensure all tracking information regarding ongoing writing projects remains current.
3. Provides to the medical writer (located either locally or remotely) assigned to a writing project, all source documentation from the electronic archive needed to author the document (e.g. statistical table sets, reference documents, subject data listings, etc.). Act as al resource on all format and style related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners.
4. Checks that study file components (eg, Investigator CV’s, protocol and amendments, sample case report form) needed for the writing of clinicall research reports (CSRs) are checked in electronic archive (eg, Documentum) on a timely basis (i.e. based on agreed upon timelines for a writing project) and meet all global standards and regulatory requirements for format (eg, heading styles, language, accuracy).
5. Assist scientific medical writers in the review of protocols and case report forms to ensure that methods are clearly presented, data categories are clear, and terminology is consistent.
6. Performs real-time edits to clinical documents during comment review and resolution meetings. Maintain departmental and project-specific style guides to reflect new agreements and changes due to SOPs,
WPs, and regulatory guidelines. Provide updates to all medical writers (internal and external) regarding style, format, and content decisions.
7. Proofreads, reformats and edits document text, as required, to ensure that all documents for a writing project meet all requirements for formatting (e.g. styles, fonts, etc.) prior to final QC, compilation and publishing. Reviews all documents and appendices to ensure consistency between and within documentsand that documents adhere to global standards and are in accordance with electronic publishing
8. Manages the review and approval of documents in the document management system using standard procedures. Work with relevant functions (e.g. regulatory, publishing and submissions groups) to maintain document flow,adhere to publishing standards, and coordinate activitiesProvide support to all contributors to a project with regard to format, style, and consistency, and ensure the use of templates available in the electronic repository.
Bachelor’s degree with no relevant medical writing experience; strong electronic documentation and word processing is required. Excellence in written and oral communication skills in English.Excellent interpersonal skills .Familiarity with clinical research, statistics, and regulatory submission requirements preferred.
As a member of the Bayer HealthCare Pharmaceuticals team, you’ll find an environment that celebrates diversity and welcomes the open exchange of ideas and individual perspectives. We are proud to offer an attractive salary along with a generous benefits package designed to support the needs of you and your family while addressing work/life balance issues.
