Job description
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies part of the Janssen Pharmaceutical Companies.
Janssen Pharmaceutical, part of the Janssen Pharmaceutical, is recruiting for a Manager/ Senior Manager Medical Writing located in Switzerland, Belgium, Netherlands, Germany, Sweden, Finland, Denmark, France, Raritan, NJ, or with consideration of being remote.
- Prepare and finalize clinical documents such as, but not limited to, clinical study reports, investigator's brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents. Take a lead role with respect to content and scientific strategy.
- Lead cross-functional document planning and review meetings. Interact with peer writers and colleagues from other departments. Able to lead program-level or submission writing teams with general supervision. Able to lead process working groups.
- Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed. You may lead the work of other medical writers, external contractors, and document specialists supporting a project.
- Responsible for establishing document timelines and strategies in accordance with internal processes, with minimal guidance.
- If a lead writer for a program: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning, setting strategy, and leading writing group for assigned program.
- Work with a high level of independence, taking responsibility on assigned projects for timing, scheduling, and tracking.
- Champion medical writing standard processes and provide recommendations for departmental process improvements.
- Maintain and disseminate knowledge of the industry, company, and regulatory guidelines.
- If a people manager:o Manage direct reports in Medical Writing. Set objectives for individual team members. Regularly meet with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
Qualifications
Education:
University/college degree is required. Masters or PhD preferred.
- At least 8 years of relevant pharmaceutical/scientific experience is required; at least 6 years of relevant medical writing experience is required.
- If a people manager, preferably up to 2 years of people management experience.
- Strong oral and written communication skills.
- Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
- Attention to detail.
- Able to resolve complex problems under general supervision is required.
- Demonstrate learning agility.
- Able to build and maintain solid and positive relationships with cross‐functional team members is required.
- Strong leadership skills, both in time management as well as in project/process management.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.
Primary Location
United States-New Jersey-Raritan-920 US Highway 202
Other Locations
Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Denmark, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-Finland, Europe/Middle East/Africa-France, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Sweden
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
2206046849W
shipshapebody.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, shipshapebody.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, shipshapebody.com is the ideal place to find your next job.