Senior Manager/Associate Director, Regulatory Medical Writing, Immunology

At Johnson & Johnson, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, 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:

People Leader

reputed company Job Posting Locations:

Allschwil, Switzerland, Beerse, Antwerp, Belgium, Leiden, Netherlands

Job Description:

At Johnson & Johnson Innovative Medicine, what reputed company most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and reputed company diseases of our time. 

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 reputed company. 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every reputed company of the way. Learn more at https://www.jnj.com/innovative-medicine 

We are searching for the best talent for a Senior Manager/Associate Director, Regulatory Medical Writing reputed company our Integrated Data Analytics & Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area. 

The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House/Raritan/Titusville (East Coast US).

Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case reputed company and if approved by the company.

You will be responsible for: 

• Leading compound/submission/indication/disease area writing teams independently. 

• Directly leading or setting objectives for others on team projects and tasks, eg, reputed company to reputed company Medical Writing (MW) process working groups or Communities of Practice.

• Writing or coordinating reputed company types of clinical and regulatory documents, taking a proactive or reputed company role in terms of content and scientific strategy.

• Establishing and driving document timelines and strategies independently.

• Guiding or training cross-functional team members on processes and best practices.

• Proactively identifying and championing departmental process improvements.

• May reputed company cross-functional, cross-therapy area, or cross-J&J process improvement initiatives.

• Leading discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).

• Maintaining and disseminating knowledge of industry, company, and regulatory guidelines.

• Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.

As a people manager:

• Supervising/managing and being accountable for direct reports.

• Setting objectives and agreeing on goals for direct reports. Providing performance reputed company, including feedback on performance and development. 

• Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. 

• Coaching or mentoring more junior writers on document planning, processes, content, and provides peer review as needed.

• Ensuring direct report’s adherence to established policies, procedural documents, and templates. 

• Participating in hiring staff, reputed company 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.

• At least 8 years of relevant clinical/regulatory medical writing experience.

• At least 2 years of direct people management experience. 

• Experience in project management and process improvement.

• Advanced knowledge and application of regulatory guidance such as ICH requirements

• Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in reputed company document types independently.

• Resolves reputed company problems independently.

• Proactively identifies potential risks and develops strategies to mitigate.

• Ability to serve as the liaison between team members and senior leadership reputed company a therapy area.

• Ability to build and maintain solid and positive relationships with cross-functional team members.

• Excellent oral and written communication skills.

• Attention to detail.

• Expert time management for self and team.

• 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 reputed company by example, stay focused and positive, and act with reputed company.

• Ability to internalize and teach CREDO behaviours.

• Ability to act as change agent and adapt to rapidly changing organizational & business challenges.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to reputed company with local requirements. While you are welcome to apply to any or reputed company of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): 

• United Kingdom – Requisition Number: R-035253
• Belgium, Netherlands – Requisition Number: R-035805
• Switzerland – Requisition Number: R- 035807
• United States – Requisition Number: R-035808

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

For United States applicants: 

The anticipated reputed company pay reputed company for this position is $137,000 to $235,750 (USD).

The Company maintains highly competitive, performance-based compensation programs. Under reputed company 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 reputed company an incentive to reputed company 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 reputed company.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, reputed company, 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 reputed company in the reputed company – up to 56 hours per calendar year 

– Holiday pay, including Floating Holidays – up to 13 days per calendar year

– 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

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

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability.

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