Regulatory Medical Writer
2 days ago
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
We are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.jnj.com.
Company OverviewFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Our vision is to create a world where everyone has the opportunity to live a healthy life. We're driven by our passion for innovative solutions, scientific excellence, and patient-centered care. We strive to push beyond boundaries and challenge ourselves to think differently, so we can improve the lives of patients around the world.
Job DescriptionKey Responsibilities- Prepare and finalize clinical documents: Clinical study reports, investigator's brochures, protocols, summary documents, briefing books, and regulatory responses.
- Perform document QC: Generate list of abbreviations and references, conduct literature searches, and other basic tasks.
- Participate in cross-functional document planning and review meetings: Interact with peer writers and colleagues from other departments.
- Lead compound or document teams: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for establishing document timelines and strategies in accordance with internal processes.
You will be responsible for preparing and finalizing clinical documents, performing document QC, participating in cross-functional document planning and review meetings, and leading compound or document teams.
If you have strong attention to detail, excellent communication skills, and experience in medical writing, this could be the perfect role for you.
RequirementsQualifications- Education: University/college degree required. Masters or PhD preferred.
- Experience and Skills: At least 2 years of relevant pharmaceutical/scientific experience; previous regulatory medical writing experience is preferred.
- Strong oral and written communication skills: Ability to learn and recognize how to best interpret, summarize, and present statistical and medical information.
- Emerging leadership skills: Both in time management as well as in project/process management.
- Able to resolve problems independently and under supervision: Demonstrate learning agility and able to build solid and positive relationships with cross‐functional team members.
To be considered for this position, you must have a university/college degree and at least 2 years of relevant pharmaceutical/scientific experience.
A background in medical writing is preferred, but not necessary.
BenefitsWe offer a comprehensive compensation package, including:
- Estimated salary range: $89,000 - $143,750 per year.
- Performance-based bonuses: Eligible for an annual performance bonus based on individual and company performance.
- Health insurance: Medical, dental, and vision coverage.
- Retirement plan: Company-sponsored pension and savings plan (401(k)).
- Vacation time: Up to 120 hours per calendar year.
- Sick leave: Up to 40 hours per calendar year (56 hours in Washington state).
- Holiday pay: 13 days per calendar year.
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