Analyst II, Medical Writing, Immunology

4 weeks ago


Toronto, Canada Johnson & Johnson Innovative Medicine Full time

Join to apply for the Analyst II, Medical Writing, Immunology role at Johnson & Johnson Innovative Medicine. 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 Medical Writing Professional Locations Allschwil, Switzerland; Beerse, Antwerp, Belgium; High Wycombe, Buckinghamshire, United Kingdom; Spring House, Pennsylvania, United States of America; Toronto, Ontario, Canada 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. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Analyst II, Medical Writing, Immunology. This role is available in all states within the United States. Remote work options may be considered on a case‑by‑case basis and, if approved by the Company. Requisition Numbers: United States: R‑02370; Belgium & Netherlands: R‑026119; United Kingdom: R‑026119; Switzerland: R‑026110; Canada: R‑042336. Responsibilities Develops within the medical writing role within the pharmaceutical industry. Works in a team environment and matrix. Performs routine tasks per established procedures. Gains knowledge and applies internal standards, regulatory, and publishing guidelines. With increasing skill, uses internal systems, tools, and processes. Writes and coordinates basic documents, preparing more complex documents within the TA and across TAs in accordance with experience level. Functions as a lead writer on a project, indication, or a compound either early‑or late‑stage in life cycle under close supervision. Participates in process working groups. Writes and coordinates basic clinical documents such as Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, and initial IBs. Writes, contributes to, and/or coordinates low to medium complexity clinical and regulatory documents such as Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses under supervision. Performs document QC, completes list of abbreviations or references, conducts literature searches, and performs other basic tasks with supervision as needed. Participates in and may lead cross‑functional document planning and review meetings. Works in a team environment with some guidance while increasing independence for longer‑term activities. Takes an active role on assigned projects with respect to timing, scheduling, and tracking. Interacts with cross‑functional colleagues on document content and champions MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes. Learns and adheres to SOPs, templates, best practices, policies, Medical Writing Style Guide. Regularly meets with manager and mentors and attends departmental meetings. Attends cross‑functional meetings as appropriate. Completes all time reporting, training, and metrics database, and project tracking updates as required. Maintains and applies knowledge of industry, company, and regulatory guidelines. Guides or trains cross‑functional team members on processes and best practices. Leads early‑or late‑stage compound writing teams with supervision, as required. Qualifications Education: A university/college degree in a scientific discipline is required. An advanced degree (Masters, PhD, MD) is preferred. A minimum of 2 years of relevant pharmaceutical/scientific experience is required. A minimum of 2 to 4 years of regulatory medical writing experience is required, depending on tasks performed and level of supervision needed. Strong oral and written communication skills. Attention to detail. Ability to function in a team environment. Organizes time well. Demonstrates learning agility. Builds solid and productive relationships with cross‑functional team members. Gains experience in interpreting, summarizing, and presenting statistical and medical information to ensure quality and accuracy of content with supervision. Emerging leadership skills, project and process management, time management, influencing, negotiating, assertiveness, taking initiative. Resolves basic problems independently and more complex problems with supervision. Develops and applies knowledge of regulatory guidance documents such as ICH requirements. Compensation The expected pay range for this position is $89,000 to $143,750. This position is eligible for an annual performance bonus and various benefits. Benefits Vacation – up to 120 hours per calendar year. Sick time – up to 40 hours per calendar year (up to 56 hours in Washington). Holiday pay, including floating holidays – up to 13 days per calendar year. Work, Personal and Family Time – up to 40 hours per calendar year. EEO Statement 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. #J-18808-Ljbffr



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