- Erfahrung
- 3+ Jahre
- Gehalt
- USD 105,000 – USD 115,000 / year
- Stellenangebote
- 1
- Veröffentlicht
- vor 2 Stunden
- Arbeitsmodus
- Arbeiten von zu Hause
- Ausbildung
- Bachelor’s degree in a relevant scientific discipline
- Teilnahmeberechtigung
- Applicants must be based in the United States and bring scientific writing experience relevant to medical, clinical, or regulatory documentation. Candidates with medical device clinical evaluation experience are especially encouraged to apply.
- Wieder aufnehmen
- Bewerbung erforderlich
Stellenbeschreibung
Overview
This is a remote medical writing opportunity for a candidate based in the United States. The hiring process and application handling are managed by a partner company, which will also oversee the next steps.
The position is suited to a scientific communications professional who wants to support healthcare progress through precise, high-impact clinical and regulatory documentation. The work centers on producing accurate medical writing outputs for clinical evaluations, investigations, and submissions tied to regulatory requirements.
You will review clinical evidence, perform literature research, and turn complex scientific information into clear, compliant documents. The role also involves working with teams across medical, regulatory, quality, and research functions, with a focus on patient safety, compliance, and innovative healthcare outcomes.
This opportunity is a strong fit for a detail-driven medical writer who brings scientific depth, excellent communication ability, and the confidence to handle complex assignments independently.
Key Responsibilities
- Take ownership of, and contribute to, clinical evaluation report development and related documents, covering planning, evidence review, data interpretation, and analysis.
- Assist with post-market clinical follow-up work by reviewing clinical data, evaluating literature, and preparing supporting documentation.
- Perform thorough, structured literature searches using research databases and search tools to back clinical evaluations, regulatory needs, and state-of-the-art reviews.
- Interpret clinical evidence from both manufacturer sources and published research to inform clinical development direction.
- Draft, revise, and quality-check clinical study materials such as protocols, investigator brochures, periodic reports, and clinical study reports.
- Make sure documents align with regulatory expectations and are appropriate for submission to authorities and external audiences.
- Prepare and support scientific manuscripts, abstracts, and conference materials based on study data and evidence.
- Work with medical experts to maintain scientific accuracy, data quality, and publication alignment.
- Help improve clinical affairs workflows, procedures, and standard operating practices.
- Coordinate with internal teams and outside partners such as clinical vendors, research organizations, and healthcare specialists.
Requirements
- A bachelor’s degree in a relevant scientific field, or an equivalent mix of education and experience.
- At least 3 years of experience in medical writing.
- Prior work on clinical evaluations in the medical device sector is strongly preferred.
- Medical writing certification is considered an added advantage.
- Solid understanding of clinical affairs rules and guidance, including EU MDR (2017/745), MEDDEV, MDCG, ISO standards, and ICH clinical research guidance.
- Experience with literature searches using platforms such as PubMed, Embase, or similar databases.
- Familiarity with literature review and reference management software such as DistillerSR and EndNote is preferred.
- Excellent written and spoken communication skills, with the ability to explain complex scientific concepts in a simple and accurate way.
- Strong analytical, planning, and problem-solving abilities, along with the capacity to handle several priorities at once.
- Proven project management skills and a track record of delivering quality work on schedule.
- Comfort working independently while also contributing effectively to cross-functional teams.
- Professional communication skills for interactions with physicians, clinical specialists, and outside collaborators.
- Advanced working knowledge of Microsoft Office tools, including Outlook, Word, Excel, and PowerPoint.
- Ability to adapt to shifting priorities, urgent deadlines, and project-based travel when required.
Benefits
- Approximate annual compensation of $105,000 to $115,000, depending on experience, skills, and qualifications.
- Remote work flexibility anywhere within the United States.
- Coverage for health, dental, and vision insurance.
- 401(k) plan with employer matching contributions.
- Paid time off plus wellness programs.
- Employee assistance resources and support services.
- Life insurance, short-term disability, and long-term disability coverage.
- Flexible spending accounts for health and dependent care.
- Commuter support benefits.
- Parental leave and caregiver leave offerings.
- Tuition reimbursement support.
- The chance to contribute to meaningful healthcare innovation and global medical progress.
Additional Information
This role is presented by a partner organization that manages applications and candidate progression. The selection process uses AI-assisted matching to review applications against the role’s core requirements, create a shortlist, and pass suitable candidates to the hiring employer. Final decisions, including interviews and assessments, are handled by the employer’s internal team.
By applying, you acknowledge that your personal data may be processed for candidacy evaluation and shared with the hiring employer in line with applicable data protection laws, including GDPR where relevant. The recruitment process may also use AI tools to assist with application review, resume analysis, and response assessment; however, human judgment remains part of the final hiring decision. You may request details about data processing or exercise applicable privacy rights such as access, correction, deletion, or objection.
Note
Compensation is listed as an annual salary range rather than a stipend. No specific number of openings, start date, or application deadline was provided.