Manager, Medical Writing, Immunology

Johnson And Johnson; Maidenhead; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

Johnson & Johnson in Maidenhead, United Kingdom is seeking a Manager, Regulatory Medical Writing in Immunology to lead a team and oversee regulatory document preparation across programs.

You will drive quality, timelines, and cross-functional collaboration within Integrated Data Analytics & Reporting, while mentoring junior writers and coordinating with other departments in global submissions.

Qualifications

• Minimum of University/college degree required.
• Masters or PhD preferred.
• 8+ years of pharma/scientific experience; 6+ years in medical writing.
• 2+ years of people management preferred.

Responsibilities

• Prepare and finalize all types of clinical documents.
• Lead in a team environment and set objectives.
• Guide cross-functional teams on processes and content.
• Mentor junior staff and manage internal/external writers.

Skills

Medical Writing

Regulatory Writing

Leadership

Cross-functional

Education

University/College degree

Job description

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Medical Affairs Group

Job Sub Function

Medical Writing

Job Category

People Leader

All Job Posting Locations

Maidenhead, Berkshire, United Kingdom

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. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: R-101381 Belgium & Netherlands - Requisition Number: R-104942 Switzerland- Requisition Number: R-104947 United Kingdom- Requisition Number: R-104948 Canada- Requisition Number: R-104951

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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!

Responsibilities

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 goal-setting, 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.
• Excellent 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 cross-functional 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