The Clinical Writer is responsible for researching, creating, editing, and coordinating the production of clinical documents; with a focus 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.

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. Works with and serves 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 for scientific literature within the various online repositories as well as 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

Required Qualifications:

• Bachelors degree in a relevant discipline
• 1+ years proven experience performing literature reviews, analyzing data, and communicating outputs.
• 1+ years' experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
• 1+ years' experience writing scientific documents for regulatory or journal submission. Experience presenting scientific/clinical evidence in a written and oral manner to cross-functional teams.
• 1+ years knowledge of MDR and MEDDEV requirements.

Preferred Qualifications:

• Master's degree
• 1+ years medical device and CER writing experience
• Experience with Medical devices
• Demonstrated ability to build positive constructive relationships with cross-functional team members. Demonstrated high level of personal integrity, emotional intelligence, and flexibility.

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, 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.

0-20% travel.

This position is not eligible for employer-based visa sponsorship.

Disclosure as required by applicable law, the annual salary range for this position is 62,000 to 95,000. 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:

CONMED offers a wide array of benefits to fit your unique needs. Visit our for more information.

• 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 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.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3.