[Hiring] Sr Medical Affairs Specialist - Regulatory Writing and Scientific Communications @Dexcom
Role Description
Dexcom 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 related documentation, as well as design and management of compliant literature search strategies that support these deliverables and align with corporate objectives. Additionally, you will develop abstracts, posters, and manuscripts that communicate Dexcom evidence to external audiences – aligned with GPP/ICMJE guidance and internal publication processes.
• Lead 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 all documentation with corporate objectives
• Manage project scope, schedule, risk/issue tracking, and stakeholder communication
• Write high-quality scientific publications, including manuscripts, abstracts, posters, and oral presentations, in accordance with company policies and industry guidelines (eg, GPP)
• Ensure timely feedback, review cycles, and adherence to deadlines for deliverables
• Assist with tracking for scientific communication-related activities
Qualifications
• Advanced degree in relevant scientific field
• Minimum of 3-5 years of experience in regulatory/clinical/medical writing within medical devices, biotech, or pharma
• 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-priority projects simultaneously
• Excellent written and verbal communication skills
Requirements
• Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related experience
Benefits
• A front row seat to life changing CGM technology
• Learn about our brave #dexcomwarriors community
• A full and comprehensive benefits program
• Growth opportunities on a global scale
• Access to career development through in-house learning programs and/or qualified 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 within commuting distance of your assigned Dexcom site (typically 75 miles/120km)
• If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option
Salary
• $95,900.00 - $159,900.00
Apply tot his job
Apply To this Job
Dexcom 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 related documentation, as well as design and management of compliant literature search strategies that support these deliverables and align with corporate objectives. Additionally, you will develop abstracts, posters, and manuscripts that communicate Dexcom evidence to external audiences – aligned with GPP/ICMJE guidance and internal publication processes.
• Lead 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 all documentation with corporate objectives
• Manage project scope, schedule, risk/issue tracking, and stakeholder communication
• Write high-quality scientific publications, including manuscripts, abstracts, posters, and oral presentations, in accordance with company policies and industry guidelines (eg, GPP)
• Ensure timely feedback, review cycles, and adherence to deadlines for deliverables
• Assist with tracking for scientific communication-related activities
Qualifications
• Advanced degree in relevant scientific field
• Minimum of 3-5 years of experience in regulatory/clinical/medical writing within medical devices, biotech, or pharma
• 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-priority projects simultaneously
• Excellent written and verbal communication skills
Requirements
• Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related experience
Benefits
• A front row seat to life changing CGM technology
• Learn about our brave #dexcomwarriors community
• A full and comprehensive benefits program
• Growth opportunities on a global scale
• Access to career development through in-house learning programs and/or qualified 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 within commuting distance of your assigned Dexcom site (typically 75 miles/120km)
• If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option
Salary
• $95,900.00 - $159,900.00
Apply tot his job
Apply To this Job