Manager Medical Writing XTA

6084-Janssen Research & Development, LLC Legal Entity; Spring House (PA); Hybrid; USD 117,000 - 201,000; Full time

Benefits offered by this job

Base pay range

Annual bonus

Medical benefits

Pension/401(k)

Job summary

Johnson & Johnson is seeking a Manager, Regulatory Medical Writing to support across therapeutic areas within Integrated Data Analytics & Reporting (IDAR). Hybrid work is available with potential remote options, location spanning multiple countries including the United States.

You will be responsible for preparing and finalizing clinical documents, leading teams, and guiding process improvements while coordinating cross-functionally with scientific strategy and timelines.

Qualifications

• 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 is required.
• Submission leadership experience preferred.
• English fluency required.

Responsibilities

• Prepare and finalize all types of clinical documents.
• Lead in a team environment.
• Independently lead projects with content and scientific strategy, timing, scheduling, and tracking.
• Mentor or train cross-functional team members on processes and best practices.
• Represent Medical Writing in industry standards groups if applicable.

Skills

Medical Writing

Regulatory Writing

Submission Management

Leadership

Communication

Education

Bachelor’s or higher degree

Master or PhD preferred

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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: Professional

All Job Posting Locations: Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America

Job Description

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

We are searching for the best talent for a Manager, Regulatory Medical Writing to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located High Wycombe, UK; Leiden, Netherlands; Neuss, Germany; Paris, France; Beerse, Belgium; or Horsham / Spring House / Raritan, United States.

The position is Hybrid (3 days onsite weekly). (Remote work options may be considered on a case-by-case basis and if approved by the company). 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 – Requestion Number: R-091734 United Kingdom - Requisition Number: R-091690 Netherlands, Germany, France, Belgium- Requisition Number: R-091731 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Are you ready to join our team? Then please read further!

You will be responsible for:

• Preparing and finalizing all types of clinical documents.
• Leading in a team environment.
• Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking.
• Leading or setting objectives for others on team projects and tasks, eg, leading process working groups.
• Guiding or training cross-functional team members on processes and best practices.
• Potentially leading project-level/submission/indication writing teams.
• Proactively providing 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 participating in medical writing and cross-functional meetings.
• Maintaining knowledge of industry, company, and regulatory guidelines.
• Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed; overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
• Interacting with senior cross-functional colleagues to strengthen coordination between departments.
• May be representing Medical Writing department in industry standards working groups.

Qualifications /Requirements

• 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 is required!
• Submission leadership experience preferred.
• Experience of multiple therapeutic areas preferred.
• Attention to detail.
• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.
• English fluency required.
• 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.
• Ability to commute to site.

Benefits United States

• The anticipated base pay range for this position is 117,000 to 201,250 USD on an annual 1.0 FTE basis.
• The Company maintains highly competitive, performance-based compensation programs.
• Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
• The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.
• Bonuses are awarded at the Company’s discretion on an individual basis.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Additional Description for Pay Transparency

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 https://www.jnj.com/.

The anticipated base pay range for this position is : $117,000.00 - $201,250.00

Required Skills

• Medical Writing
• Regulatory Writing
• Submission Management

Preferred Skills

• Business Writing
• Clinical Research and Regulations
• Clinical Trials Operations
• Coaching
• Collaboration
• Copy Editing
• Data Synthesis
• Industry Analysis
• Medical Affairs
• Medical Communications
• Process Improvements
• Proofreading
• Quality Validation
• Standard Operating Procedure (SOP)
• Tactical Planning
• Technical Credibility

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