Medical Writer - Clinical Compliance

3M Health Care Business Group$124K — $170K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree or higher in a scientific or technical discipline.
  • Minimum five years of experience in the medical device industry.
  • At least five years of experience in medical writing or technical writing in a regulated industry.
  • Strong scientific writing and communication skills.
  • Experience with EU MDR requirements.

Responsibilities

  • Author and coordinate Clinical Evaluation Plans and Clinical Evaluation Reports.
  • Collaborate with cross-functional teams to analyze and assess clinical data.
  • Support internal and external audits as a subject matter expert.
  • Maintain up-to-date clinical evaluations throughout the product lifecycle.
  • Contribute to Summary of Safety and Clinical Performance reports with managerial guidance.

Benefits

  • Flexible working arrangements with a remote position.
  • Health and wellness programs to support physical and financial well-being.
  • Wide range of medical, dental, and vision coverage options.
  • Flexible Spending Accounts for healthcare and dependent care.
  • Paid time off and retirement benefits.
Full Job Description
Job Description:

Medical Writer - Clinical Compliance(Solventum)

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You'll Make in this Role
As a Medical Writer - Clinical Compliance you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

  • Authoring and coordinating Clinical Evaluation Plans and Clinical Evaluation Reports (CEPs/CERs), to support new product introductions and sustaining product activities in the Dental Solutions business unit.
  • Collaborating with cross-functional teams to collect, analyze, and assess clinical data in compliance with EU MDR and other global regulatory requirements.
  • Supporting internal and external audits as a subject matter expert in clinical evaluations.
  • Maintaining up-to-date clinical evaluations across the full lifecycle of medical devices.
  • Contributing to Summary of Safety and Clinical Performance (SSCP) reports and regulatory responses with guidance from manager/supervisor.


Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

  • Bachelor's degree or higher from an accredited institution, preferably in a scientific or technical discipline (Biology, Chemistry, Biomedical Eng, etc.) AND five (5) years of experience in the medical device industry


AND

In addition to the above requirements, the following are also required:

  • Minimum of five (5) years of experience in medical writing or technical writing in a regulated industry, preferably aligned to EU MDR requirements


Additional qualifications that could help you succeed even further in this role include:
  • Strong scientific writing and communication skills, with the ability to interpret and present clinical data
  • Dental experience in a private, public, government or military environment
  • Demonstrated experience working on cross-functional teams in a global or regulatory environment
  • Familiarity with SSCP authoring and Class III/implantable medical device regulations in the EU
  • Excellent attention to detail, time management, and organizational skills
  • Ability to manage multiple complex projects simultaneously.
  • Strategic thinking, critical thinking, reasoning, and interpretive skills
  • Proficiency in Microsoft Office applications (Excel, Teams, Word, PowerPoint) with strong analytical skills.
  • Experience utilizing AI technologies to optimize workflows, automate tasks, and enhance operational efficiency.


Work location: Remote - United States

Travel: May include up to 10% domestic

Relocation Assistance: Not authorized

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being

Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

Applicable to US Applicants Only:The expected compensation range for this position is $124,000 - $170,500, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

About 3M Health Care Business Group

3M Health Care Business Group Careers

Join the esteemed 3M Health Care Business Group, a leader in global health care innovation, and be part of a team that is dedicated to improving medical outcomes all around the world.

Explore Job Opportunities

3M Health Care Business Group offers a variety of job opportunities that allow professionals to contribute to a healthier future. The team is constantly on the lookout for passionate, creative, and solution-driven team players.

Professional Growth and Development

At 3M Health Care Business Group, career growth is fostered through unmatched training, development, and certification support. Professionals can go as far as their ambition takes them, with nearly limitless opportunities to advance within the company.

Innovative Work Environment

Engage in innovative work that pushes the boundaries of medical science and technology. The team at 3M Health Care Business Group is at the forefront of industry expertise and digital innovation, delivering targeted solutions that enhance patient care and operational efficiency.

Diversity and Leadership

Leadership at 3M Health Care Business Group is enhanced by a commitment to diversity and inclusion. The company offers diversity training that enriches the professional and personal growth of its team members, fostering an inclusive culture that values different perspectives and ideas.

Internship Programs

Internship opportunities at 3M Health Care Business Group provide a robust platform for students to gain hands-on experience, develop essential skills, and integrate into a culture of leadership and innovation. These positions are crucial stepping stones for those looking to jumpstart their careers in health care.

Benefits and Culture

The culture at 3M Health Care Business Group is built on a foundation of innovation, integrity, and respect. Employees enjoy comprehensive benefits that support both their professional careers and personal lives, ensuring a well-rounded employment experience.

Networking and Professional Development

Networking opportunities within 3M Health Care Business Group allow employees to connect with industry leaders and peers, enhancing their professional networks and opening doors to further career advancement.

Hiring Process

The hiring process at 3M Health Care Business Group is designed to identify and attract top talent. Candidates can expect a thorough interview process where they can showcase their skills and experience. Interested candidates are encouraged to tailor their resumes to highlight relevant experience and skills for the position they are applying for.

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