Current Opportunities

Tracking # 60 Industry Pharmaceutical Jobs Job Title Medical Writer Location Mid Atlantic Salary Open Job Description The role of Medical Writer involves all areas of researching, writing, and editing regulatory, preclinical, clinical, and/or medical documents, including clinical/statistical reports, study protocols, and documents for submission to regulatory authorities worldwide. The successful candidate will be responsible for managing or writing clinical study protocols and reports, manuscripts, patient information, regulatory documents, product labeling and other documentation related to pharmaceutical product development projects. An effective RBP Medical Writer has an understanding of clinical, medical, scientific, and regulatory issues related to the use of RBP products, and uses their well-developed project management and technical writing skills to edit and to coordinate the authorship, review, and approval of product labeling. Competencies · Strong knowledge and understanding of medical, scientific, and regulatory terminology and subject matter · Ability to work precisely according to procedures, rules, and regulations · Ability to approach issues from a number of perspectives, summarizing data to draw a conclusion · Excellent verbal and written communication skills, with proper use of the English language (spelling, grammar, and punctuation) · Ability to work unsupervised by taking responsibility for their own actions through excellent organizational, planning and follow-through skills · Detail oriented, with strong proofreading/editing skills · High computer literacy, with proficiency in MS Word, PowerPoint, Excel and Outlook · Ability to interact competently with colleagues from all areas of the business (e.g. medical, clinical, chemistry, manufacturing, engineering, packaging, quality assurance, regulatory affairs, marketing) to facilitate a positive, constructive and supportive work environment · Ongoing readiness to actively support colleagues toward top performance in the achievement of departmental and organizational goals · Knowledge and experience following FDA regulations and guidances Tasks · Represent Medical Writing on clinical teams with responsibility for timely and accurate completion of Medical Writing deliverables · Write or manage the writing of regulatory, preclinical, clinical, and/or medical documents that may include, but are not limited to: o Clinical Investigator Brochures, Clinical protocols (Phases I-III; IV) and clinical study outlines, o Clinical Development Plans, o Final Clinical Study Reports, o abstracts & manuscripts, o Sections of regulatory submissions, such as New Drug Applications (NDA) and Investigational New Drug (IND) applications. o Integrated Summaries of Safety (ISS), o Integrated Summaries of Efficacy (ISE), o Benefits/Risk Analyses, o Annual Reports o Product Labels/Labeling o Documentation for medical communications programs · Ensure that all documents are well organized, accurate, consistent, and in compliance with applicable regulations and company SOPs · Maintain document standardization with the use of model documents/templates to guide the development of clinical project documentation · Coordinate the creation and revision of product labeling and associated regulatory documents as follows: o Proactively interact with technical experts from a wide variety of backgrounds (e.g. medical, clinical, chemistry, manufacturing, engineering, packaging, quality assurance, regulatory affairs, marketing) in their authorship and review of regulatory labeling in finalizing labeling components. o Edit and format text to meet regulatory style, content, and format requirements o Facilitate proofreading of all regulatory text o Manage document version control o Conduct copy reviews of draft documents, and hold copy review meetings with major labeling stakeholders o Maintain records to document copy clearance activities, and capture recommended revisions and action items from copy clearance meetings o Track and implement revisions resulting from copy reviews, as recommended by product technical experts o Coordinate final document approvals o As necessary, manage the conversion of labeling to electronic formats that support regulatory requirements of FDA and other regulatory authorities o Communicate with Packaging and Manufacturing personnel to implement the new or revised approved labeling o Coordinate with Marketing and Sales personnel to update affected marketing materials and activities · Support the creation and review of company Standard Operating Procedures and Work Instructions, as needed to support technical writing and labeling-related activities · Independently and proactively identify and recommend improvement in the efficiency and effectiveness of RBP procedures for ongoing excellence in meeting the needs of our business and of our patients and customers. Qualifications The successful candidate should minimally possess: · Bachelor’s degree in a biomedical science · At least 5 years medical writing experience in the regulated drug development industry · Excellent writing skills Relocation Package Yes Interview Expenses Yes Benefits Package Yes