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About the Role

This position supports the Immunology therapeutic area within the Regulatory Medical Writing team of Integrated Data Analytics & Reporting (IDAR). The role involves preparing and finalizing clinical documents, leading teams, and managing direct reports.

Responsibilities

• Prepare and finalize all types of clinical documents.
• Lead in a team environment with a high level of independence on assigned projects regarding content, scientific strategy, timing, scheduling, and tracking.
• Set objectives for others on team projects and tasks, such as leading process working groups.
• Guide or train cross-functional team members on processes and best practices.
• Lead project-level/submission/indication writing teams.
• Proactively provide recommendations for departmental process improvements.
• Act as the primary point of contact and champion for medical writing activities for the clinical team when serving as a lead writer for a program.
• Plan and lead the writing group for assigned programs.
• Actively participate in medical writing and cross-functional meetings.
• Maintain knowledge of industry, company, and regulatory guidelines.
• Coach or mentor junior staff on document planning, processes, content, and provide peer review.
• Oversee the work of other medical writers, external contractors, and document specialists supporting a project.
• Interact with senior cross-functional colleagues to strengthen inter-departmental coordination.
• Represent the Medical Writing department in industry standards working groups.
• Manage direct reports in Medical Writing, setting objectives and conducting regular meetings for development, project assignments, and issue resolution.
• Make decisions on hiring, onboarding, conducting career and talent development discussions, goal-setting, and performance discussions for staff.

Requirements

• Minimum of University/college degree required.
• Masters or PhD preferred.
• At least 8 years of relevant pharmaceutical/scientific experience.
• At least 6 years of relevant medical writing experience.
• 2 years of people management experience.
• Attention to detail.
• Excellent oral and written communication skills.
• Expert project/time management skills.
• Strong project/process leadership skills.
• Ability to interpret, summarize, and present statistical and medical information accurately.
• Ability to resolve complex problems independently.
• Demonstrate learning agility.
• Ability to build and maintain positive relationships with cross-functional team members.
• Solid knowledge and application of regulatory guidance documents such as ICH requirements.

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

Location

• Allschwil, Basel-Country, Switzerland
• Beerse, Antwerp, Belgium
• High Wycombe, Buckinghamshire, United Kingdom
• Leiden, Netherlands
• Spring House, Pennsylvania, United States of America
• Toronto, Ontario, Canada

Work Type

• Remote work options may be considered on a case-by-case basis

Experience Level

• 8 years of relevant pharmaceutical/scientific experience
• 6 years of relevant medical writing experience
• 2 years of people management experience

Education Level

• University/college degree
• Masters or PhD preferred

Salary/Compensations

• $117,000 to $201,250

Benefits

• Annual performance bonus
• Medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
• Consolidated retirement plan (pension) and savings plan (401(k)).
• Long-term incentive program.
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year (varies by state)
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

About the Company

• Johnson & Johnson believes health is everything and strives to build a world where complex diseases are prevented, treated, and cured.
• Their strength in healthcare innovation, spanning Innovative Medicine and MedTech, positions them to deliver breakthroughs for humanity.
• The company fosters an inclusive work environment respecting diversity and individual merit, guided by Our Credo.
• Innovative Medicine expertise is patient-informed, driving science-based advancements to develop tomorrow's medicines.
• The Immunology team focuses on developing transformational medicines for immunological disorders, aiming to restore health to millions.
• Learn more at https://www.jnj.com/innovative-medicine

Equal Opportunity

• Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law.
• Actively seeks qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
• Committed to providing an inclusive interview process and offers accommodations for individuals with disabilities.