Medical Writer

Medical Writer Kelly® Science & Clinical is seeking Medical Writer professionals who are eager to bring the latest scientific discoveries to life in order to create a brighter, safer and healthier future for all.

If you’re passionate about shaping the world we live in and ready for a new challenge, this may be the perfect opportunity for you.

The Medical Writer oversees the development and execution of various high-quality medical-writing initiatives across all therapeutic areas within Research and Development.

A strong priority and focus will be placed on ensuring documents are written in accordance with guidelines, SOPs, and applicable regulations.

You will be an active collaborator with local and global cross-functional program teams for devices, drugs, biologics, and/or other products for human use.

Responsibilities: Author high-quality clinical documents, contributing scientific/technical expertise, knowledge related to clinical development, and experience related to document preparation.

Analyze, synthesize, and incorporate relevant clinical/medical literature into Communicate with and work effectively and productively with multidisciplinary, international teams while executing project plan.

Act as medical writing subject matter expert on clinical study teams.

Ensure documents comply with current local and international regulations, laws, scientific and regulatory guidance, Good Clinical Practice, and internal policies and procedures.

Independently identify document-content issues and resolve/implement or escalate for resolution.

Coordinate the review, approval, submission, and production of final documents in accordance with established.

Coordinate with team leads to plan resource needs and timelines for high-quality, properly formatted medical writing deliverables.

Evaluate documents for organization, clarity, language/grammar, consistency, and scientific.

Ensure document deliverables are clear, concise, and adherent to guidelines, SOPs, and applicable regulations.

Provide expert advice to project teams on matters related to production of clinical documents, regulatory submissions, and/or presentations/publications.

Coordinate and integrate data and information from a variety of sources, including clinical study data and study results (i.e., tables, figures, and listings) and peer-reviewed literature to support various clinical initiatives.

Consolidate input from internal and external contributors to develop appropriate/key document messaging.

Establish general proficiency of applicable therapeutic area, gathering relevant product knowledge for application in assigned.

Minimum Qualifications: Bachelor’s/Master’s Degree in Science required.

At least 5 years of medical-writing experience in the pharmaceutical, medical device, health sciences, or biotech industry.

Demonstration of strong medical-writing skills (e.g., peer-reviewed publications, scientific presentations; IND/NDA modules, IDE/PMA submissions, investigator brochures, study protocols, CSRs).

American Medical Writing Association (AMWA) or other medical-writing certification.

Excellent verbal and written English, including understanding of English language usage and standardized-writing styles.

Strong understanding of trial master files and electronic trial master files.

Able to work on multiple projects simultaneously, while maintaining competing priorities, timelines, and quality of deliverables.

Able to anticipate obstacles and proactively develop solutions to achieve project goals.

Able to work on New Drug Applications.

(NDA) Readily adaptable to changes in priorities.

Knowledge of FDA and/or EMA regulations, GCP, ICH guidelines, and/or ISO 14155.

Understanding of clinical product development, clinical trials, and global regulatory submissions.

Able to effectively engage in an open, constructive, and continuous dialogue.

Able to successfully develop solutions to complex problems that are consistent with company objectives.

Experience in medical-database searches (e.g., Medline, PubMed.) TJP2021_SPEC TJP2021_SCT You should know: Your safety matters Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies.

A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you.

Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be.

Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ® At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential.

In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?).

Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity.

Equal Employment Opportunity is The Law.

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