30 March, 2022
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
- 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
· 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