.Johnson & Johnson Innovative Medicine is recruiting for an Analyst II to join the Regulatory Medical Writing team to support our Immunology therapeutic area.
The position may be located in North America, Europe, or other global locations.
Are you ready to join our team?
Then please read further.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.
Through our expertise in Innovative Medicine and MedTech, 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 https://www.Jnj.Com/ .For 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.Key Responsibilities: Depending on your experience, your responsibilities will cover a range of activities including:Prepare and finalize clinical documents such as, but not limited to, 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 and may lead cross-functional document planning and review meetings.Interact with peer writers and colleagues from other departments.If a lead writer for a compound or document: 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, with some mentorship from functional management and clinical team, as needed.Learn and adhere to SOPs, templates, best practices, policies, and Medical Writing Style Guide.Acquire, maintain, and apply knowledge of the industry, company, and regulatory guidelines.Qualifications: Education: University/college degree required.
Masters or PhD preferred.Experience and Skills: We would value a colleague with these qualities:At least 2 years of relevant pharmaceutical/scientific experience; previous regulatory medical writing experience is preferred