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Manager, Regulatory Medical Writing - 2306152361W

Description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Medical Writing, Interventional Oncology. The position can be located anywhere within the US, but it is preferred to have a candidate in the East Coast in the PA/NJ area.

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

Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, pulmonary hypertension, and retinal disease.

We are recruiting for a Manager to join the Medical Writing team to support our new Interventional Oncology organization. Are you ready to join our team? Then please read further!

Key Responsibilities:

• Directly set objectives for the Interventional Oncology writing team; plan and forecast upcoming workload for medical writing deliverables.

• Ensure document deliverable quality coming out of the Interventional Oncology writing team. Regularly meet with contract writers to ensure appropriate support on assignments (e.g., training, coaching, resources, etc.) and to resolve issues as they arise.

• Lead cross-functional document planning and review meetings. Able to lead program-level or submission writing teams with general supervision. Able to lead process working groups.

• Responsible for establishing document timelines and strategies in accordance with internal processes, with minimal guidance.

• Prepare and finalize clinical documents such as, but not limited to, clinical study reports, investigator's brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents. Take a lead role with respect to content and scientific strategy.

• Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed.

• Champion medical writing standard processes and provide recommendations for departmental process improvements. Maintain and disseminate knowledge of the industry, company, and regulatory guidelines.

• Interact with cross‐functional colleagues and external partners to strengthen coordination between departments as needed.

• Able to inform decision on hiring and onboarding new contract writers with support and guidance from direct manager, Oncology TA Head, and INTO senior management.

• Act as MW Single Point of Contact for INTO projects, attending Clinical Functional Trial Team and Compound Development Team meetings as needed to provide strategic and tactical input into MW deliverables.

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 (preferably in the Oncology therapeutic area) is required.

• Strong oral and written communication skills is required.

• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently is required.

• Able to build and maintain solid and positive relationships with cross‐functional team members is required.

• Strong leadership skills, both in time management as well as in project/process management is required.

• Experience coordinating or managing the work of contractors is a plus.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $139,000 to $224,825.

The anticipated base pay range for this position in all other US locations is $113,000 - $195,500.

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

• Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.

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

Primary Location NA-US-Pennsylvania-Spring House

Other Locations NA-United States

Organization Janssen Research & Development, LLC (6084)

Job Function Medical Writing

Req ID: 2306152361W