Associate Scientific Medical Writer

Major Responsibilities

• Uses project management skills to track, review and ensure timely completion of high quality documents.
• Authors protocols, clinical study reports and narratives for medical writing projects assigned, based on source materials provided by the document team and input from the team’s study experts. Completes writing tasks satisfying all regulatory requirements and quality standards and meeting all project timelines.
• Translates clinical study reports and other clinical documents, as required, into the local language to meet regulatory submission requirements for individual countries.  Oversees the translation of clinical documents to meet regulatory submission requirements for individual countries.
• 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.).
• Acts as a central resource on all format and style related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners. Maintains departmental and project-specific style guides to reflect new agreements and changes due to SOPs, WPs, and regulatory guidelines.  Provides updates to all medical writers (internal and external) regarding style, format, and content decisions.
• Works with key interface partners to facilitate the completion of clinical study reports and their appendices.  Ensures clinical documents adhere to global standards and are in accordance with electronic publishing Standards.  Checks that study file components (eg, Investigator CV’s, protocol and amendments, sample case report form) needed for the writing of clinical research reports (CSRs) are checked into the electronic archive (eg, eDMS) 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).
• 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 and performs QC checks of all documents and appendices to ensure consistency between and within documents.  Assist scientific medical writers in the review of protocols and clinical study reports to ensure that methods are clearly presented, data categories are clear, and terminology is consistent. 
• Manages the review and approval of documents in the document management system using standard procedures. Transfers clinical study documents from the individual study files into the electronic archive used to compile the final medical documents.
• Ensures that all team members have the required document management and review tool training required to review, approve and sign documents and trains them if necessary
• Is responsible for training new Medical Writing Specialists and exploring methods to increase job efficiency and develop quality improvement techniques, together with the Regional Head and the Global Head of Global Medical Writing

Requirement

• Bachelor’s degree or equivalent with at least 3-5 years of experience in the pharmaceutical industry in total, including a minimum of 3 years in Medical Writing and demonstrated working knowledge of scientific principles. OR
• Master’s degree or equivalent with at least 2-3 years of experience in the pharmaceutical industry in total, including a minimum of 2 years in Medical Writing and demonstrated working knowledge of scientific principles.  OR
• PhD degree or equivalent with approximately 1 year of experience in the pharmaceutical industry in total, including approximately 1 year in Medical Writing and demonstrated working knowledge of scientific principles.
• AND
• The incumbent must have familiarity with clinical research, statistics, and regulatory guidances, standards and requirements pertaining to regulatory medical writing world wide (eg ICH, FDA, EMEA).
• The incumbent must have experience in electronic document management and electronic regulatory submissions, tools and standards. 
• The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas.
• The incumbent must be a skilled user of word processing applications.