Medical Writer Job at CONMED Corporation in Largo

The Medical Writer is responsible for researching, creating, editing, and coordinating the production of clinical documents, focusing on Clinical Evaluation Plans, Clinical Evaluation Reports, and Summary of Safety and Clinical Performance Reports required for CE marked devices and other countries requiring a Clinical Evaluation Report for product registrations. This is a remote position.

Responsibilities

• Plan and develop high quality clinical documents to support Medical Solutions devices.
• Responsible for preparation and authoring of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs) as required by EU regulations for CE marked devices.
• Provide input to product development and post-market sustaining core teams. Work with and serve as a leader to cross-functional teams.
• Work with internal teams to gain cross-functional inputs and approvals.
• Consistently apply applicable global regulations and guidelines, as well as ConMed policies and procedures.
• Synthesize responses to inquiries from the Notified Body.
• Perform and continue to evaluate scientific literature within various online repositories while looking for ways to improve and increase productivity of the literature process.
• Support periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives.
• Develop and manage CER project plans and timelines. Plan and deliver intra-departmental and cross-functional communication to ensure critical information is transmitted to relevant parties in a timely manner.
• Perform periodic reviews of risk documentation, product labeling, and marketing claims as part of the clinical evaluation process. Perform comprehensive literature searches to support assigned product lines.
• Participate in audits.
• Assist in development of processes. Provide clinical review/approval of marketing materials. Maintain and update spreadsheets tracking the status for CER projects.
• Collect and maintain all documents necessary to ensure compliance with SOP. May support registration of products in non-EU countries.
• Complete training by established due dates.
• Create resolutions for continued EU market access.
• Assist with other projects as directed by Sr. Writer or Clinical managers.

Qualifications

• Associates degree required.

Preferred

• Bachelor's in a relevant discipline preferred.
• 2+ years medical device and CER writing experience preferred.
• Experience with medical devices in the operating room setting as a CST, CSFA, or RN.
• Experience with medical devices preferred.
• Proven experience performing literature reviews, analyzing data, and communicating outputs.
• Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical, or Regulatory role.
• Experience writing scientific documents for regulatory or journal submission. Experience presenting scientific/clinical evidence in a written and oral manner to cross-functional teams.
• Demonstrated ability to build positive constructive relationships with cross-functional team members. Demonstrated high level of personal integrity, emotional intelligence, and flexibility.
• Knowledge of MDR and MEDDEV requirements.

What is expected of you and others at this level

• Excellent scientific writing skills; experience creating and performing literature searches in Embase, PubMed, and Google Scholar; experience using Microsoft Word, Adobe, Excel, and PowerPoint.
• Strong data extraction and analysis skills; proactive with a sense of urgency in managing job responsibilities; self-motivated and able to work independently.
• Analytical thinking and inquisitive mindset; ability and desire to develop good working relationships internally and externally.

Sponsorship: This position is not eligible for employer-visa sponsorship.

Disclosure as required by applicable law, the annual salary range for this position is 67,496 to 97,000. The actual compensation may vary based on geographic location, work experience, education, and skill level. The salary range is CONMED’s good faith belief at the time of this posting.

Benefits:

• Competitive compensation.
• Excellent healthcare including medical, dental, vision, and prescription coverage.
• Short & long term disability plus life insurance -- cost paid fully by CONMED.
• Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period.
• Employee Stock Purchase Plan -- allows stock purchases at a discounted price.
• Tuition assistance for undergraduate and graduate level courses.

Know someone at CONMED?

Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!

CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, citizenship status, or veteran status.

Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.