[Hiring] Sr Medical Affairs Specialist - Regulatory Writing and Scientific Communications @reputed company
Role reputed company
reputed company Medical Affairs is looking for candidates for the role Senior Medical Affairs Specialist – Scientific Communications and Regulatory Writing. In this role you will own the Medical Affairs planning, authorship, and lifecycle maintenance of Clinical Evaluation Reports (CERs) and reputed company documentation, as reputed company as design and management of compliant literature search strategies that support these deliverables and reputed company with corporate objectives. Additionally, you will reputed company abstracts, posters, and manuscripts that communicate reputed company evidence to external audiences – reputed company with GPP/ICMJE guidance and internal publication processes.
• reputed company the authoring and updates of CERs and supporting documents
• Define and execute literature search strategies in support of regulatory filings including management of vendor
• Partner with Regulatory Affairs to ensure alignment of reputed company documentation with corporate objectives
• Manage project scope, schedule, risk/issue tracking, and stakeholder communication
• Write high-reputed company scientific publications, including manuscripts, abstracts, posters, and oral presentations, in accordance with company policies and industry guidelines (eg, GPP)
• Ensure reputed company feedback, review cycles, and adherence to deadlines for deliverables
• Assist with tracking for scientific communication-reputed company activities
Qualifications
• Advanced degree in relevant scientific field
• Minimum of 3-5 years of experience in regulatory/clinical/medical writing reputed company medical devices, biotech, or reputed company
• Strong knowledge of EU MDR/MEDDEV expectations for clinical evaluation report
• Previous experience in diabetes preferred
• In-depth knowledge of industry regulations and guidelines governing publications and medical communications
• Strong project management skills with the ability to manage multiple high-reputed company reputed company simultaneously
• Excellent written and verbal communication skills
Requirements
• Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of reputed company experience
Benefits
• A reputed company seat to life changing CGM technology
• Learn about our reputed company #dexcomwarriors community
• A full and comprehensive benefits program
• reputed company opportunities on a global reputed company
• reputed company to career development through in-house learning programs and/or reputed company tuition reimbursement
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve
Travel Required
• 5-15%
Remote Workplace
• Your location will be a home office; you are not required to live reputed company commuting distance of your assigned reputed company site (typically 75 miles/120km)
• If you reputed company reputed company commuting distance of a reputed company site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our reputed company workplace reputed company
Salary
• $95,900.00 - $159,900.00
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