Job Function:
Medical Affairs Group
Job Sub Function:
Medical Writing
Job Category:
People Leader
All Job Posting Locations:
Spring House, Pennsylvania, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
About Immunology
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for Manager, Medical Writing, Immunology in Spring House, PA.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
Purpose: Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team is recruiting for a Manager, Regulatory Medical, Immunology. This position will support our Immunology therapeutic area. Are you ready to join our team? Then please read further!
You will be responsible for:
- Prepare and finalize all types of clinical documents.
- Lead in a team environment. Work with a high level of independence and take a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking.
- Lead or set objectives for others on team projects and tasks, eg, lead process working groups.
- Guide or train cross-functional team members on processes and best practices.
- May lead project-level/submission/indication writing teams.
- Proactively provide recommendations for departmental process improvements.
- If a lead writer for a program: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
- Actively participate in medical writing and cross-functional meetings.
- Maintain knowledge of industry, company, and regulatory guidelines.
- Coach or mentor more junior staff on document planning, processes, content, and provide peer review as needed; may oversee the work of other medical writers, external contractors, and document specialists supporting a project.
- May interact with senior cross-functional colleagues to strengthen coordination between departments.
- May represent Medical Writing department in industry standards working groups.
- 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.
- Make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goalsetting, and performance discussions.
Qualifications/Requirements:
Education:
Minimum of University/college degree required. Masters or PhD preferred.
Experience and Skills:
- At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required.
- 2 years of people management experience is preferred.
- Attention to detail.
- 3Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.
- Expert project/time management skills.
- Strong project/process leadership skills.
- Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
- Able to resolve complex problems independently.
- Demonstrate learning agility.
- Able to build and maintain solid and positive relationships with crossfunctional team members.
- Solid knowledge and application of regulatory guidance documents such as ICH requirements.
Required Skills:
Preferred Skills:
Analytics Insights, Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Copy Editing, Cross-Functional Collaboration, Developing Others, Inclusive Leadership, Industry Analysis, Leadership, Medical Affairs, Medical Communications, Performance Measurement, Quality Validation, Standard Operating Procedure (SOP), Tactical Planning, Team Management
The anticipated base pay range for this position is :
$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Companys long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation 120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year
Holiday pay, including Floating Holidays 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave 120 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave 60 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave 20 hours in a 52-week rolling period10 days
Volunteer Leave 6 hours per calendar year
Military Spouse Time-Off 20 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
