Role: Technical Project Manager for Clinical Affairs

This role will oversee & support Indegene’s Clinical Evaluation team by providing technical expertise in the development and maintenance of Clinical Evaluation Reports (CERs) and CER-related regulatory compliance documents.

The Technical Project Manager has to lead the team to work with global medical devices clients & provide guidance for required activities and documentation to comply with global CER/PMS/PMCF regulations & is deemed as a subject matter expert on guidelines and regulations regarding the clinical evaluation process and its related documentation (e.g., CEP, CER, PMS Plan, PMCF Plan, PMCF Report, and SSCP).

WHAT YOU’LL DO

• Provide CER SME support as needed by CER teams during development of new CERs and remediation of existing CERs
• Provide an early review of all drafted clinical evaluation documents to ensure all regulatory requirements have been met, as well as a final review & approval of all documents prior to the document being released to the client
• Support the client to define the strategic approach to leverage the transition to European Medical Device Regulation (EU MDR) with regard to clinical evaluation
• Review content of Clinical Evaluation Plan and Report, Post market clinical follow ups (PMCF) Plans and report, Post Market Surveillance (PMS) plan and reports
• Lead individual CER teams in the resolution plan for any identified deficiencies during CER development or as a result of deficiencies identified by the client
• Support the CER Process Owner with the development of the Clinical Evaluation (CE) Plan, CER GQP/GQT/GG (for EU-CER Accepting Countries as well as ROW)
• Develop and provide a training program and continuous education curriculum for both CER Medical Writers and Clinical Evaluators
• Provide SME support for China CER regulations; guiding the CER development teams to requirements per applicable regulations
• Maintain knowledge of current Clinical evaluation related regulations (globally)
• 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.
• Develop and update new policies, as appropriate, for processes and procedures relating to the clinical evaluation process, and train key personnel on them.
• Function independently as a decision-maker on clinical evaluation related regulatory issues.
• Conceptualize and design scientific content to communicate information to identified audience
• Guide team on systematic literature review to establish state of the art of current medical devices, evaluation of product specific literature and data for similar competitor and alternative devices
• Support review of the scientific content for various medical affairs deliverable’s such as posters, newsletters, brochures, and manuscripts across wide range of therapeutic areas.

EDUCATION AND EXPERIENCE YOU’LL BRING

REQUIRED

• Bachelor’s Degree is required; in the sciences, engineering, health care/medicine, or similar discipline highly preferred.
• Minimum 10 years experience:
• Scientific/research background; training and experience in science, engineering, or medical fields; understanding of research design, study methodology, and statistics; experience in the medical device industry.
• Must have comprehensive experience developing and authoring Clinical Evaluation Plans and Clinical Evaluation Reports.
• Must have thorough understanding of the EU MDR 2017/745, MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev 4, MDCG Guidance on clinical evaluations, SSCP, PMCF plans and reports, and other guidance, regulations, standards and guidelines related to medical devices, clinical studies, and quality systems.
• Understanding of medical devices or an overall understanding of the medical field.
• Working knowledge of EU MDR and MEDDEV 2.7.1 Rev 4.
• Strong flair and passion for technical writing.
• Strong written and verbal communication/presentation skills.
• Being up-to-date with the latest technical/scientific developments and relating them to various projects.
• Excellent leadership capabilities and strong management skills to:
• To respond to new demands and challenges while working effectively in ambiguous situations
• To work in a multicultural and cross-functional environment to facilitate discussion and resolution of different views
• Well-developed interpersonal skills with excellent verbal and written communication skills, public speaking and teaching skills; Excel (Pivot Table & V-Lookups, reporting, strongly preferred), Word, Outlook, PowerPoint, & SharePoint

PREFERRED

· 3-5+ years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in medical device industry.

• · 1-3+ years of experience writing, reviewing or leading development of CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4, the medical device directives (MDD 93/42/EEC; AIMDD 90/385/EEC) and the EU MDR 2017/745.

Apply through below link

Manager -Clinical Affairs Medical Devices | Indegene | LinkedIn