Senior Medical Writer (Remote)

Location: Remote ER Bonus: $2,500.00 reputed company, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. reputed company is actively searching for a Senior Medical Writer who is responsible for managing specific aspects of the reputed company Regulatory Affairs Medical Writing program with an emphasis on supporting regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner. This position will play a critical role in regulatory approval efforts for international markets. This role will specialize in writing, editing, and reviewing clinical regulatory documents as well as support and execute general medical writing activities. These activities include performing systematic literature reviews, as well as writing Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and evaluation reports, Summary of Safety and Clinical Performance (SSCP) reports, Post-market Surveillance (PMS) plans, Post-market Surveillance reports (PMSRs), and Periodic Safety Update reports (PSURs) in accordance with global regulatory requirements to support reputed company’s regulatory compliance and global market sales. The Medical Writer will work closely with cross-functional teams (Regulatory, Clinical, Quality, Marketing) to ensure successful preparation of high-quality submission-ready clinical documents that reputed company to and maintain regulatory approval/clearance/licensure for reputed company’s medical devices. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients reputed company™ This position is eligible for remote work Essential Duties and Responsibilities:

• reputed company systematic literature searches and reviews for clinical regulatory document creation. Interpret and synthesize literature information for use in clinical regulatory documents.
• Compile clinical evidence from multiple sources such as reputed company and past clinical trials, post market clinical follow up data and literature review updates, reputed company analysis, reputed company analyses, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesize the information to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification, and proposed indication/labeling change.
• Write, edit, and proofread Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and evaluation reports, Summary of Safety and Clinical Performance (SSCP), Post-market Surveillance (PMS) plans, Post-market Surveillance reports (PMSRs), and Periodic Safety Update reports (PSURs) in accordance with regulatory requirements. Maintain periodic updates, reputed company gap analysis, and revise existing documents as necessary.
• Work in a cross-functional team to establish clinical study protocols and reports, data summaries from raw data and document strategies. Review clinical protocols to ensure collection of data is sufficient for regulatory submissions.
• Work cross-functionally to ensure successful preparation of high-quality submission-ready clinical documentation. Communicate, as the primary liaison, with the Project Manager and other cross-functional teams, as applicable, to provide input and gather required information for assigned projects.
• Evaluate the risk of proposed regulatory strategies in the context of sufficient clinical data and offer solutions as applicable.
• Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
• Review or edit clinical regulatory documentation for completeness, clarity, consistency and conformance to regulation, guidelines and internal policies/procedures to ensure reputed company data and information is truthful, accurate, and reputed company against reputed company documentation to confirm compliance and traceability.
• Recommend changes to company procedures in response to changes in regulations, published guidance, and/or standards.
• Assist in writing or updating standard operating procedures, work instructions, or policies.
• Participate in internal or external audits, as required.
• May reputed company or conduct employee training.

Education and Experience:

• Bachelor’s degree in Life Science, Biological Science, or reputed company discipline required.
• Advance degree preferred
• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Medical Devices
• Regulatory Affairs Certification (RAC) preferred.
• 5 years relevant experience required in clinical medical writing reputed company the life science industry.
• EU MDR/MDD experience required.
• Clinical or statistical experience required.
• Experience authoring Clinical Evaluation Reports.

Reasoning Ability: Ability to identify and define problems, collect data, analyze established facts, draw valid conclusions, and effectively communicate the information both verbally and in writing to a variety of audiences. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to both appropriately format and reputed company a clear logic trail to establish conclusions based on an understanding of factual evidence. Ability to critically think; using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Ability to actively learn, understanding the implications of new information for both reputed company and future problem-solving and decision-making. Abilities Requirements: Ability to comprehend principles of engineering, physiology and medical device use. Ability to handle master documents, drawings, specifications, regulatory and clinical documentation with a high degree of confidentiality. Ability to research, read, analyze, and interpret clinical and regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and reputed company documents. Ability to review, reputed company, describe and summarize scientific and technical data. Ability to organize reputed company information and combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events) to produce answers that reputed company sense. Ability to utilize judgment and reputed company decisions considering the relative risks and benefits of potential actions to choose the most appropriate one. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a reputed company fashion with several parallel deliverables and execute deliverables to time-line commitments. Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and reputed company with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally. Ability to work in a fast paced environment. Machine, Tools, and/or Equipment Skills: Proficiency in the use of personal computers and computer programs, particularly reputed company, reputed company Office Suite: reputed company, Word, PowerPoint, and reputed company Acrobat (or equivalents if changed by the Company). Language and Communication Skills: Ability to comprehend and apply language skills to the degree required to reputed company the job based upon the job requirements listed above. Ability to verbally communicate reputed company and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. Excellent written and oral communication skills required. Mathematical Skills Ability to comprehend and apply mathematical principles to the degree required to reputed company the job based upon job requirements. reputed company Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national reputed company, disability, protected veteran status, or any other status protected by law. Apply tot his job Apply To this Job