Senior Medical Writer
Bridgewater, NJ, US
Scientific
Bachelors Degree
Full Time, Temporary
Experienced (Non-Manager)
Remote
Biotechnology/Pharmaceuticals
First Shift (Day)
Bridgewater, NJ, US
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
Remote
Scientific
Bachelors Degree
First Shift (Day)
Job details
Senior Medical Writer
Kelly Science and Clinical is seeking a Senior Medical Writer for our client a leading Pharmaceutical company in Bridgewater, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust the experts hiring experts
Schedule: HYBRID 3 days on site 2 days remote
Monday through Friday day shift
Possibly remote – if remote worker must be open to traveling to Bridgewater, NJ at times during the assignment
Length of assignment: two years
Pay $60 – 65 an hour with flexibility
Responsibilities
- Author key documents, ensure quality review, and adhere to timelines for critical deliverables.
- Prepare documents including, but not limited to:
- Clinical study reports
- Marketing application summaries
- Health authority meeting briefing documents
- Other integrated data summary reports
- Contribute medical writing expertise to Project and Submission teams for report preparation and production of registration dossiers.
- Ensure a consistent presentation style for clinical documents to maintain quality and ease of review, adhering to company standards.
- Work effectively with the company’s document management system, tools, templates, and procedures to ensure efficient document and dossier publishing.
- Ensure medical writing activities meet quality standards, expectations, and adhere to applicable corporate SOPs, Work Practices, policies, guidelines, and regulations.
- Stay current on ICH, FDA, EMA, and Health Canada guidelines regarding medical writing.
Qualifications/Training:
- A scientific degree in life sciences is required.
- Knowledge and experience with pharmaceutical development processes, including preparation of documents for marketing applications, responses, and meetings.
- Experience:
- Previous experience as a Medical Writer ideally 5 years plus
- Understanding of basic statistics, pharmaceutical safety, and investigational research.
- Excellent oral and written English skills.
- Technical proficiency with electronic document management and word processing software, particularly strong Microsoft Word skills.
- Ability to work autonomously and proactively.
- Possesses a sense of urgency and is deadline-oriented.
- Works in an accurate, meticulous manner; is detail-oriented.
- Displays a solid work ethic, professionalism, organizational ability, and follow-up skills.
What happens next
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what’s next in your career is what we’re all about,
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Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.