Manager, Medical Writing
Description
Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Description
Position Overview
The Medical Writing Manager provides leadership, strategic direction, and expertise to meet EU MDR compliance and other clinical research objectives for assigned product area/responsibilities within Shockwave Medical (SWM). Key activities include oversight, planning, generation, and timely completion of clinical evaluation deliverables (CEPs, CERs, PMCFERs) and other clinical documents intended for regulatory submissions. Responsibilities include cross-functional team participation for the development of such clinical documents and direct management/supervision of other medical writers and external consultants assisting/preparing such clinical documents. This position may expand to support other clinical evidence documents, including the support of the clinical sections of a PMA/PMAs (US Class III), IDE (US Class II/III), 510K (US Class III), other international medical device applications or other technical writing needs as applicable.
Essential Job Functions
- Responsible for clinical evaluation deliverables for SWM products to maintain EU MDR compliance and obtain new product registrations.
- Accountable for literature search protocols, overseeing literature searches, appraising, and analyzing results for both product-specific and state-of-the-art literature.
- Obtains clinical input and drives the completion of PMCF Evaluation Reports (PMCFERs).
- Manages CER timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools.
- Oversees generation of clinical evaluation deliverables and other clinical documents by other clinical research personnel and/or external medical writers.
- Provides strategic oversight and guidance on compliant document execution and generation.
- Role includes management responsibilities for one or more direct reports with coaching/training as needed.
- Provides input/assistance for Regulatory/ technical documents that include clinical study results (e.g., labelling, summary of safety and effectiveness, instructions for use, etc.).
- Interacts with cross-functional teams to define the plan and strategy for development of the CER or other clinical sections for new products requiring CE Mark or International Product Registration.
- Stays current with product regulatory guidance documents; assists with procedure gap assessments.
- Ensures consistency across SWM product lines for clinical research documents. Maintain templates for clinical evaluation documents. Lead procedure updates and template changes as needed.
- Provides input for project budget planning when external medical writers/technical editors are utilized. May assist in selecting providers, managing vendor contracts, and ensuring expenditures are within budgetary guidelines.
- Participates in and supports audits from regulatory agencies as necessary.
- Enforces company Quality System standards. Ensures document content quality by consistently managing and organizing information for accuracy and readability/clarity.
- Responsible for communicating business related issues or opportunities, providing visibility of issues and enabling corrective and preventive action to be taken as needed.
- Maintain compliance with corporate policies, state, federal and international regulations.
- Performs other duties assigned as needed.
Requirements:
- Bachelor’s degree in a scientific or engineering field of study; Advanced degree preferred.
- Minimum of 10 years of relevant job experience required with 2+ years of experience managing others or other equivalent experience.
- Experience within the medical device industry and knowledge of Clinical Evaluation Report regulatory requirements, evidence generation, and Clinical Evaluation Report (CER) document creation is required.
- Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting is preferred.
- Able to understand and interpret statistical results of clinical studies and understands good data management practices.
- Ability to identify critical information needs and identify stakeholders within clinical evaluation assessment and report development.
- Strong oral communication, presentation, project management and prioritization skills.
- Excellent interpersonal relationships; Must be able to work effectively on cross-functional teams.
- Excellent critical and analytical thinking skills.
- Must have a high level of attention to detail, accuracy, and organization.
- Must be able to manage multiple projects across various disciplines.
- Up to 10% travel may be required.
Market Range:
San Francisco Bay Area (SFBA) Market Range: $136,000 - $170,000
All Other US Locations (Outside of SFBA): $116,000 - $145,000
Exact compensation may vary based on skills, experience, and location.
Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:
Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance
Perks: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer