Associate Director, Regulatory Medical Writing - Oncology

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

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, Titusville, New Jersey, 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

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-010375

Canada - Requisition Number: R-011450

Netherlands, Germany, Spain, France - Requisition Number: R-011453

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

This can be a hybrid (3 days in office and 2 remote) OR Remote role available in all countries listed above. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

We are searching for the best talent for Associate Director, Regulatory Medical Writing - Oncology.

Purpose

• Able to function as a lead writer on any compound independently.
• Leads in setting functional tactics/strategy.
• Leads project-level strategy (eg, submission team, global program team, clinical team).
• May represent therapeutic area (TA) head at high-level and cross-functional TA meetings and has some independent decision-making authority.
• Able to write and coordinate complex documents within and across TAs independently.
• Contributes to and champions internal standards, regulatory, and publishing guidelines.
• Contributes to and champions the improvement of internal systems, tools, and processes.
• Able to lead process working groups.
• Able to oversee the work of external contractors.
• May have additional major responsibility with supervision:
• Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
• Larger organizational responsibility (eg, manage a subset of TA).
• If a people manager:
• Manages a team of internal medical writers (direct reports).
• Accountable for the quality of deliverables and compliance of direct reports.
• Actively participates in resource management and hiring decisions.
  

You Will Be Responsible For

• Able to lead compound/submission/indication/disease area writing teams independently.
• Directly leads or sets objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
• Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
• Establishes and drives document timelines and strategies independently.
• Guides or trains cross-functional team members on processes and best practices; coaches or mentors more junior writers.
• Proactively identifies and champions departmental process improvements.
• May develop and present best practices or innovations to internal or external audiences.
• May lead cross-functional, cross-TA, or cross-J&J process improvement initiatives.
• Leads discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).
• Maintains and disseminates knowledge of industry, company, and regulatory guidelines.
• Completes all time reporting, training, metrics database, and project tracking (functional planning) updates as required in relevant company systems.
• Coaches or mentors more junior staff on document planning, processes, content, and provide peer review as needed.
• If applicable, has lead MW responsibilities for providing guidance on deliverables, content, etc.

• Interacts with senior cross-functional colleagues and external partners to strengthen coordination between departments.
• May represent MW in industry standards working groups.
• As a MW lead, is the primary point of contact for MW activities for the cross-functional team (eg, clinical).
• If a people manager:
• Supervises/manages and is accountable for direct reports.
• Sets objectives and agrees on goals for direct reports. Provides performance oversight, including feedback on performance and development.
• Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
• Ensures direct report’s adherence to established policies, procedural documents, and templates.
• Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.
  

Qualifications / Requirements

• A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
• At least 10 years of relevant pharmaceutical/scientific experience is required.
• At least 8 years of relevant clinical/regulatory medical writing experience is required.
• Experience in project management and process improvement is required.
• If a people manager: at least 2 years of people management experience is required.
• Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
• Resolves complex problems independently.
• Advanced knowledge and application of regulatory guidance documents such as ICH requirements
• Interacts with senior cross-functional colleagues and external partners, often requiring coordination across multiple functions and groups.
• Proactively identifies potential risks and develops strategies to mitigate.
• Identifies and resolves problems related to development and implementation of new service offerings/deliverables.
• Ability to serve as the liaison between team members and senior leadership within a TA.
• Excellent oral and written communication skills.
• Attention to detail.
• Expert time management for self, direct reports (if applicable), and teams.
• Ability to build and maintain solid and productive relationships with cross-functional team members.
• Expert project management skills, expert project/process leadership.
• Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
• Ability to delegate responsibility to junior writers.
• Ability to lead by example, stay focused and positive, and act with integrity.
• Ability to internalize and teach CREDO behaviors.
• Ability to act as change agent and adapt to rapidly changing organizational & business challenges.
• If a people manager: Strong people management skills.
  
  

The anticipated base pay range for this position is 137000 to 235750.

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

Additional information can be found through the link below.

http://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.