Medical Writer

The Medical 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.

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.

• Provides 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

• Creating resolutions for continued EU market access

• Assist with other projects as directed by Sr. Writer or Clinical managers

Qualifications

• Associates degree required

• 1 year medical device and CER writing experience required

Preferred

• Bachelors in a relevant discipline preferred.

• 2+ 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, 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.

Benefits:

CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page 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. The Know Your Rights: Workplace Discrimination is Illegal Poster and Pay Transparency Nondiscrimination Provision reaffirm this commitment.

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.