Sr Medical Writer/ Sr Clinical Evidence Specialist

SELECT SOURCE INTERNATIONAL

Select Source International (SSI) has been serving major corporations for more than 15 years. At SSI, we believe in building a corporation with only the strongest and most capable individuals. Our world-class consultants have the expertise to meet our clients’ demands. Here at SSI, we pride ourselves on the fundamental belief that our team is essential to our company's growth. We assist our consultants every step of the way in order to match them to the best possible position for their skills.

Job Title:Sr MedicalWriter/ Sr Clinical Evidence Specialist

Location: Remote

Duration: 24 Months

Job Description

Top 3:

Strong understanding of regulatory requirements & experience in writing regulatory reports including Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP), Post Market Clinical Follow-up (PMCF) Plan, PMCF- Report

Experience in Clinical Evidence planning and/or development (e.g. creating surveys, identifying data needed to substantiate claims, developing literature search protocols, defining endpoints, etc.)

Experience in a clinical or industry setting with knowledge of cardiovascular disease device therapies

Education Required: Bachelor’s degree

Years’ Experience Required: Minimum of 4 years of clinical/medical/scientific writing experience, or advanced degree with a minimum of 2 years of clinical/medical/scientific writing experience

The Senior Clinical Evidence Specialist oversees the clinical evaluation process for cardiac medical devices in compliance with applicable clinical and regulatory standards.

This specialist provides scientific and/or medical expertise, analytical thought processes and a robust, systematic clinical evaluation approach in order to continuously collect, analyze and assess clinical data on Cardiac Rhythm (CRM) products throughout their lifecycle.

The specialist collaborates with cross-functional teams on establishing clinical safety and performance objectives for medical devices and defining the associated appraisal and analysis plans for various types of data sets across the lifecycle of the medical device.

The specialist plans and develops clinical evaluation plans, reports, post market clinical follow-up plans and reports, summary of safety and clinical performance, and other related deliverables.

This individual also manages project schedules for each document to ensure timely execution.

Best Regards,

Deepak Singh Tomar

Cell: 612-474-9508

Deepakt(at)selectsourceintl(dot)com

13911 Ridgedale Drive Suite 230 Minnetonka, Minnesota 55305

Disclaimer: Select Source International (SSI) does not tolerate discrimination against any applicant on the basis of gender, sexual orientation, race, religion, national origin, ethnicity, veteran status, disability, age, sexual preference or any other protected status designated by federal, state or local law. It is SSI’s policy to affirmatively recruit, hire, train, assign, transfer, evaluate, compensate, provide benefits, promote, demote, layoff, recall, and terminate employees on their own abilities, achievements and experiences. This policy applies to all SSI employee activities. SSI encourages diversity in hiring, recognizing that this enriches the work environment for all SSI associates and that a broad variety of perspectives enhances decision-making and creativity.

SSI is an Equal Opportunity Employer.

Job Types: Full-time, Contract

Schedule:

• 8 hour shift
• Monday to Friday

Travel requirement:

• No travel

Education:

• Bachelor's (Preferred)

Experience:

• Clinical Evidence: 4 years (Preferred)
• writing regulatory reports (CEP, CER): 4 years (Preferred)
• cardiovascular disease device therapies: 2 years (Preferred)

Work Location: Remote