Johnson & Johnson
Senior Analyst Regulatory Medical Writing, Immunology
Johnson & Johnson, Spring House, Pennsylvania, United States, 19477
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 https://www.jnj.comJob Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America About the Role
Senior Analyst Regulatory Medical Writing, Immunology. The role can be located High Wycombe, United Kingdom; Beerse, Belgium; Leiden, Netherlands; Neuss, Germany; or Springhouse / Raritan / Titusville, United States. Hybrid working is expected for applicants living within commutable distance of a J&J office (3 days onsite per week). Remote work options may be considered on a case‑by‑case basis for those outside the commutable area, and if approved by the company. Responsibilities
Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents. Leading cross‑functional document planning and review meetings. Interacting with cross‑functional colleagues on document content and championing MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed. Actively participating in or leading process working groups. Coaching or mentoring more junior staff on document planning, processes, and content. Providing peer review as needed. Qualifications
A university/college degree in a scientific field is required. An advanced degree (eg, Masters, PhD, MD) is preferred. At least 6 years of relevant pharmaceutical/scientific experience including at least 4 years of regulatory medical writing experience. Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in all document types under general supervision. Proficiency in written and spoken English, together with excellent oral and written communication skills. Strong attention to detail. Ability to collaborate with cross‑functional global teams across time zones, requiring some flexibility in your daily routine. Builds productive relationships with cross‑functional team members. Strong leadership skills, both in project and process management and in time management (influencing, negotiating, assertiveness, taking initiative). Resolved complex problems under supervision. Organizes time well, and demonstrates learning agility. Additional Information
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): Belgium, Netherlands, Germany: R‑037404; United Kingdom: R‑036329; United States: R‑039471. Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. For United States applicants, the anticipated base pay range for this position is $105,000 to 169,050 (USD). The company maintains highly competitive, performance‑based compensation programs and is eligible for an annual performance bonus in accordance with the applicable plan. 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 (up to 56 hours per calendar year for employees residing in Washington), holiday pay including floating holidays up to 13 days, and 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 outside 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. 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. Equal Opportunity
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.
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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.comJob Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America About the Role
Senior Analyst Regulatory Medical Writing, Immunology. The role can be located High Wycombe, United Kingdom; Beerse, Belgium; Leiden, Netherlands; Neuss, Germany; or Springhouse / Raritan / Titusville, United States. Hybrid working is expected for applicants living within commutable distance of a J&J office (3 days onsite per week). Remote work options may be considered on a case‑by‑case basis for those outside the commutable area, and if approved by the company. Responsibilities
Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents. Leading cross‑functional document planning and review meetings. Interacting with cross‑functional colleagues on document content and championing MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed. Actively participating in or leading process working groups. Coaching or mentoring more junior staff on document planning, processes, and content. Providing peer review as needed. Qualifications
A university/college degree in a scientific field is required. An advanced degree (eg, Masters, PhD, MD) is preferred. At least 6 years of relevant pharmaceutical/scientific experience including at least 4 years of regulatory medical writing experience. Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in all document types under general supervision. Proficiency in written and spoken English, together with excellent oral and written communication skills. Strong attention to detail. Ability to collaborate with cross‑functional global teams across time zones, requiring some flexibility in your daily routine. Builds productive relationships with cross‑functional team members. Strong leadership skills, both in project and process management and in time management (influencing, negotiating, assertiveness, taking initiative). Resolved complex problems under supervision. Organizes time well, and demonstrates learning agility. Additional Information
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): Belgium, Netherlands, Germany: R‑037404; United Kingdom: R‑036329; United States: R‑039471. Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. For United States applicants, the anticipated base pay range for this position is $105,000 to 169,050 (USD). The company maintains highly competitive, performance‑based compensation programs and is eligible for an annual performance bonus in accordance with the applicable plan. 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 (up to 56 hours per calendar year for employees residing in Washington), holiday pay including floating holidays up to 13 days, and 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 outside 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. 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. Equal Opportunity
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.
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