Associate Director, Medical Writing - Oncology
Janssen Research & Development, LLC, a member of the J&J Family of Companies, is recruiting for an Associate Director, Medical Writing - Oncology, to be located in either Titusville, NJ; Raritan, NJ; Spring House, PA, or High Wycombe, UK. This position may require up to 10% travel.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
- Prepare and finalize all types of clinical and regulatory documents with in the Oncology therapeutic area, taking a proactive lead role in terms of content and scientific strategy. Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency.
- Lead in a team environment, and work with a high-level of independence, while leading assigned projects with respect to timing, scheduling, and tracking.
- Directly lead and set objectives for others on team projects and tasks.
- Guide and train cross-functional team members on processes, best practices; coach and mentor more junior writers.
- Lead writing teams with independence.
- Proactively identify and champion departmental process improvements.
- Develop and present best practices to external audiences.
- Lead cross-functional/cross-Therapeutic Areas, cross-J&J process improvement initiatives.
- Able to function as a Lead Writer, with principal responsibilities to include, but be not limited to:
- Primary point of contact for Clinical/Global Program Team for medical writing activities.
- Responsible for functional planning and metrics database updates for assigned program.
- Responsible for championing medical writing best practices on assigned program.
- Responsible for setting strategy and leading writing group on health authority submissions.
- Eventually able to function as a people manager, with principal responsibilities to include, but not be limited to:
- Supervise/manage others on the team and set objectives for individual team members.
- Regularly meet with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
- Make decisions on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, leads in goal-setting and end of year calibration reviews and performance discussions, and contribute to compensation planning.
- A Bachelors Degree with at least 10 years of relevant pharmaceutical/scientific experience, OR a Masters Degree with at least 8 years of relevant pharmaceutical/scientific experience is required.
- An advanced degree, such as MS or PhD, is preferred
- At least 8 years of relevant medical writing experience is required.
- Extensive experience writing clinical regulatory documents such as, but not limited to clinical trial protocols, clinical study reports, Summaries of Clinical Efficacy and Safety/Clinical Overviews, health authority briefing documents and response documents is required.
- Demonstrated ability to interpret and organize scientific data (e.g. written clinical and/or regulatory documents for drug development, published manuscripts, etc.) is required
- Experience with MS Office Suite (Excel, Word, PowerPoint) is required
- Experience using AMA, ICH, or similar guidelines is preferred
- Experience with medical writing document standards and processes is preferred
- Experience using document repository software (e.g. Documentum) is preferred
- Research experience (including compilation of research reports or publications) in academia or the pharmaceutical industry or as part of a PHD, Pharm.D or postdoctoral program is preferred
- Experience in project management and process improvement is required.
- Excellent oral and written communication skills are required.
- Ability to lead in a team environment is required.
- Advanced knowledge and application of regulatory guidance documents such as ICH requirements is preferred.
- Fluency (both oral and written) in English (completely comfortable communicating on a detailed, professional level) is required.
United States-New Jersey-Titusville-
North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Janssen Research & Development, LLC. (6084)
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