Clin Eval Med Writer - Exempt

LanceSoft Inc

Saint Paul, MN(remote)

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Adverse Events, Analysis Skills, Clinical Assessment, Clinical Trial, Cross-Functional, Database Administration, Documentation, Maintain Compliance, Medical Writing, People Management, Problem Solving Skills, Project/Program Management, Regulations, Regulatory Compliance, Regulatory Reports, Requirements Management, Writing Skills

LOCATION

Saint Paul, MN

POSTED

30+ days ago

Join our dynamic team as a Clinical Evaluation Medical Writer and contribute to impactful projects from the comfort of your home in Virtual, MN. This remote position offers the flexibility to work 40 hours a week while engaging with cross-functional teams to deliver outstanding results. Key Responsibilities Review and summarize scientific literature, ensuring thorough documentation and reporting of complaints/adverse events. Create responses for audit and submission queries, maintaining a comprehensive database of peer-reviewed literature. Appraise, analyze, and summarize clinical evidence from various sources, conducting comprehensive literature searches and critical evaluations. Develop state-of-the-art reports on product families for regulatory purposes and maintain plans and reports for regulatory authorities. Review and approve documentation related to device development, ensuring compliance with regulatory agencies’ guidelines on clinical evaluation requirements. Qualifications Bachelor’s degree with a minimum of 4 years of experience, or an advanced degree with a minimum of 2 years of experience. Proven experience in Clinical Evaluation Report (CER) writing. Strong project management skills with the ability to work effectively with cross-functional teams. Practical knowledge and demonstrated competence within the job area, typically obtained through advanced education combined with experience. Additional Information This role typically involves working independently with general supervision on larger, moderately complex projects. You will be responsible for setting objectives for your job area to meet project milestones, and you may have some involvement in cross-functional assignments. While innovation and complexity are part of the job, the problems faced are generally not complex. Communication is primarily internal, with occasional external interactions for problem-solving. You may provide guidance to entry-level professionals and support staff, leveraging your specialized knowledge and skills to achieve desired results.

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/