Senior Medical Writer/Project Manager Clinical Evaluation

The Opportunity

The function of a Senior Medical Writer / Project Manager supporting our Structural Heart Clinical Evaluation Products combines understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with the European Commission Guidelines on Medical Devices : Clinical Evaluation : A Guide for Manufacturers and Notified Bodies under Directives 93 / 42 / EEC and 90 / 385 / EEC (2016)requirements (MEDDEV 2.

7 / 1 Rev 4) and EU Regulation 2017 / 745.

The CER Writer / PM is recognized as a subject matter expert for guidelines and regulations regarding the clinical evaluation process and its consequent documents (e.

g., CEP, PMS / PMCF Plan, SSCP and PSUR, and CER). As such, this person has oversight of one or more medical writers guiding the development, or update, of CERs and CER-related documents.

In addition, the CER Writer / PM will interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety, performance, adverse events and risk / benefit profile of a device or devices.

Moreover, the CER Writer / PM may be requested to contribute to other activities such as risk assessment and management, and review of informational documents like the Instructions for Use.

The CER Writer / PM will sit on core team product development, CER-related SOP development and revision, and interact with regulatory agencies’ representatives as needed.

The role of Scientific CER Writer / PM plays a significant part in new product development, as well as in the subsequent evaluation of the safety and performance of a device over its lifecycle.

What You’ll Work On

• Independently creates and maintains Clinical Evaluation Plans, Clinical Evaluation Reports, and Summary of Safety and Clinical Performance SSCPs , Regulatory Responses and other related documentation
• Identifies, evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations.

Analyzes results in preparation for product applications and submissions.

• Reviews IFUs, patient guides, Risk Management files, clinical study reports, physician training materials, ensuring alignment of risk information.
• Creates, manages, or participates in timelines of deliverables by using appropriate project management tools.
• Clearly and timely communicates the timelines, project risks, and risk mitigation strategies with cross functional teams and medical writers
• Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice
• Participate in and / or lead the development of regulatory responses for Notified Body questions upon review of submissions.
• Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, Sales and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs and Reviewers).
• Provide strategic guidance on regulatory requirements pertaining to clinical data and clinical evaluation to new product development teams and sustaining teams.
• Participate in and support audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.
• Function independently as a decision-maker on CER-related regulatory issues and must assure that deadlines are met.
• Execute projects within budgetary guidelines.

Required Qualifications

• Bachelor’s Degree in related field OR an equivalent combination of education or work experience.
• Minimum 6 years related work experience with a strong understanding of specified functional area. medical devices, clinical research experience, or related industry.
• Solid understanding and application of business concepts, procedures and practices.
• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Has a sound knowledge of a variety of alternatives and their impact on their business unit.

Preferred Qualifications

• Bachelor’s Degree in Life Sciences; Master’s Degree, RN, PharmD, PhD, or MD
• Experience writing CERs and related documents in accordance with MEDDEV 2.7 / 1 Rev 4 and MDR submissions
• Understanding of regulations, standards and guidelines related to medical devices clinical studies, and quality systems, MDD 93 / 42 / EEC;

MDR 2017 / 745; MEDDEV 2.7 / 1 Rev. 4; ISO 14971; ISO 14155; ISO 13485

• Project management and / or management of people experience.
• Excellent written, verbal and presentation skills in relevant areas of clinical / technical applications.
• Strong command of medical and surgical terminology.
• Demonstrated ability to identify and adapt to shifting priorities and competing demands.
• Highly developed interpersonal skills, and strong attention to detail with accountability for ensuring deliverables are met on time.
• Technical writing experience in the medical or pharmaceutical, clinical research, medical or research industry, or combination of these skills
• Experience in structural heart / structural intervention devices.
• Certification is a plus (e.g., RAC and PMP).
1 day ago