Principal Clinical Evaluation Specialist - Shockwave Medical
About The Position
Johnson & Johnson is hiring for a Principal Clinical Evaluation Specialist – Shockwave Medical to join their team. This role is fully remote in the United States. Johnson & Johnson believes health is everything and is uniquely positioned to innovate across the full spectrum of healthcare solutions. They are pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, aiming to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease. The Principal Clinical Evaluation Specialist requires experience in the writing of medical device clinical regulatory documents. The position will mainly focus on development of Clinical Evaluation Reports (CERs) and associated documents including Clinical Evaluation Plans (CEPs), Literature Search Protocols and Reports (LSPs/LSRs) and Post Market Clinical Follow-up (PMCF) Plans and Reports. The main purpose of this job is to author and develop clinical evaluation reports (CERs) per MEDDEV 2.7.1 Rev 4 and MDR regulations to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification, and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance. This job may be expanded 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.
Requirements
- Bachelor’s degree in a scientific or engineering field of study
- 10 years of experience in medical devices with at least 5 years of direct experience in CER writing
- Expertise in medical device applicable regulations including but not limited to, MEDDEV 2.7.1, MDR, PMA, 510K, IDE and Japan
- Experience in the application of therapeutic and device knowledge to develop CERs
- Strong experience in conducting literature searches, reviews and appraisal of scientific data
- Strong experience in protocol development, writing clinical section for regulatory submission and clinical evaluation report writing
- Ability to identify critical information needs and identify stakeholders within clinical evaluation assessment and report development
- Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills
- Excellent critical and analytical thinking skills
- Must have a high level of attention to detail, accuracy and organization
- Must be able to work effectively on cross-functional teams
- Must be able to manage multiple projects across various disciplines
- Strong communication, presentation and interpersonal skills
Nice To Haves
- Business Writing
- Clinical Research and Regulations
- Clinical Trials Operations
- Coaching
- Collaboration
- Communication
- Copy Editing
- Data Synthesis
- Industry Analysis
- Medical Affairs
- Medical Communications
- Problem Solving
- Process Oriented
- Proofreading
- Quality Standards
- Research Ethics
- Standard Operating Procedure (SOP)
Responsibilities
- Authors clinical documentation- mainly the Clinical Evaluation Reports (CER) and supporting ancillary documents (CEPs, LSP, LSR, PMCF) including the clinical section of regulatory authority requests for the entire portfolio.
- Acquires knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to stay current with current literature.
- Develops comprehensive, systematic literature search protocols, supports in-depth literature searches for CERs and other clinical evidence reports and gains knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies.
- Responsible for staying informed about applicable clinical landscapes and trends.
- Provides product guidance to Clinical Office of Medical Affairs and other functions (as appropriate) to help with conducting literature searches on products/product families.
- Reviews literature, interprets and summarizes risks, analyzes alternative therapies and device specific benefits from literature; collects and summarizes primary data to support risk assessment.
- Critically appraises scientific literature and writes clinical summaries for products and procedures.
- Manages CER timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools.
- 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.
- Responsible for proofreading, editing, formatting, and reviewing comment integration and document completion/approval activities.
- Performs periodic reviews of risk documentation and product labeling; ensures appropriate updates are implemented.
- Provides clinical perspective and support to guide new product development for CE Mark/International product registration purposes.
- Authors protocols and/or routine clinical study progress reports.
- Ensures compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and OUS guidelines).
- May support other medical writing/scientific communication efforts (I.e. peer reviewed publication, white paper, podium presentation) as requested
- Other duties as required.
Benefits
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year (varies by state)
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Principal
