Analyst II, Regulatory Medical Writing

Analyst II, Regulatory Medical Writing – 2406218582W

Description

Johnson & Johnson Innovative Medicine is recruiting for an Analyst II to join the Regulatory Medical Writing team to support our Immunology therapeutic area. The position may be located in North America, Europe, or other global locations. Are you ready to join our team? Then please read further

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Key Responsibilities :

Depending on your experience, your responsibilities will cover a range of activities including:

Prepare and finalize clinical documents such as, but not limited to, clinical study reports, investigators brochures, protocols, summary documents, briefing books, and regulatory responses.

Perform document QC, generate list of abbreviations and references, conduct literature searches, and other basic tasks.

Participate in and may lead cross-functional document planning and review meetings.

Interact with peer writers and colleagues from other departments.

If a lead writer for a compound or document: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.

Learn and adhere to SOPs, templates, best practices, policies, and Medical Writing Style Guide.

Acquire, maintain, and apply knowledge of the industry, company, and regulatory guidelines.

Qualifications

Education:

University/college degree required. Masters or PhD preferred.

Experience and Skills:

We would value a colleague with these qualities:

At least 2 years of relevant pharmaceutical/scientific experience; previous regulatory medical writing experience is preferred.

Ability to learn and recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in document types under supervision.

Attention to detail.

Strong oral and written communication skills.

Emerging leadership skills, both in time management as well as in project/process management.

Able to resolve basic problems independently and complex problems under supervision.

Demonstrate learning agility.

Able to build solid and positive relationships with cross‐functional team members.

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 is 88000 to 141450.

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. 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 outside the United States will be eligible for compensation and benefits in accordance with their local market.

Primary Location NA-US-Pennsylvania-Spring House

Other Locations Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Germany, NA-United States, NA-US-Florida-Titusville, NA-Canada, Europe/Middle East/Africa-Ireland, Europe/Middle East/Africa-France, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Finland, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-Italy, NA-US-New Jersey-Raritan

Organization Janssen Research & Development, LLC (6084)

Job Function Medical Writing

Req ID: 2406218582W