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Associate director, x-ta regulatory medical writing

Imperia
Johnson & Johnson Innovative Medicine
Pubblicato il Pubblicato 23h fa
Descrizione

PAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 Functionbr/strongMedical Affairs GroupbrstrongJob Sub Functionbr/strongMedical WritingbrstrongJob Categorybr/strongPeople LeaderbrstrongAll Job Posting Locations:br/strongBeerse, Antwerp, Belgium, Dublin, Ireland, Imperia, Italy, Issy-les-Moulineaux, France, Leiden, South Holland, Netherlands, Madrid, Spain, Neuss, North Rhine-Westphalia, GermanybrstrongJob Descriptionbr/strongAt 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.brOur 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.brJoin us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for an strongAssociate Director, Regulatory Medical Writing /strongwithin our Integrated Data Analytics Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA Regulatory Medical Writing area.brThis position is open globally and may be in Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy), in addition to North America (eg, Spring House, PA, Raritan, NJ, or Titusville, NJ). While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.brThis can be a hybrid (3 days in office and 2 remote) OR Remote role available in all countries listed above. Remote work options may be considered on a case-by-case basis and if approved by the Company.brAre you ready to join our team? Then please read further!brstrongYou Will Be Responsible Forbr/strong /pulliLeading compound/submission/indication/disease area writing teams independently. /liliMay have additional major responsibility with supervision. /liliCross-functional, cross-TA, or cross-JJ initiative/collaboration. /liliLarger organizational responsibility (eg, manage a subset of TA). /liliPreparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking. /liliLeading program-level/submission writing teams independently. /liliDirectly leading or setting objectives for others on team projects and tasks. /liliGuiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers. /liliProactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes. /liliLeading cross‐functional/cross‐TA, cross‐JJ process improvement initiatives, or other large process working groups. /liliDeveloping, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences. /liliIf a lead writer for a program: /liulliPrimary point of contact and champion for Medical Writing activities for the clinical team. /liliResponsible for planning and leading the writing group for assigned program. /liliAble to function as a lead writer on any compound independently. /liliLeading discussions in Medical Writing and cross‐functional meetings as appropriate. /liliInteracting with senior cross‐functional colleagues and external partners to strengthen coordination between departments. /liliAble to oversee the work of external contractors. /li /ulliAs a people manager: /liulliManage direct reports in Medical Writing. /liliSet objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. /liliEnsures direct report’s adherence to established policies, procedural documents, and templates /liliAble to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.br/li /ul /ulstrongQualifications /Requirementsbr/strongulliUniversity/college degree in a scientific discipline is required. Masters or PhD preferred. /liliAt least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required! /liliIf a people manager, at least 2 years of people management experience. /liliMultiple therapeutic area experience preferred. /liliStrong attention to detail. /liliStrong oral and written communication skills. Fluent written and spoken English. /liliExpert project management skills, expert project/process improvement leadership. /liliExpert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills. /liliAbility to delegate responsibility to junior writers. /liliDemonstrated ability to collaborate and develop effective partnerships with key business partners and customers. /liliAbility 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.br/li /ulPlease 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):brUnited Kingdom - Requisition Number: R-020783brEurope (BE/FR/DE/IRE/IT/NL/ES)- Requisition Number: R-021380brUnited States (East Coast)- Requisition Number: R-021383brRemember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.brstrongFor United States Applicantsbr/strongThe anticipated base pay range for this position is $137,000 to $235,750 (USD)brThe 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.brEmployees 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.brEmployees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).brstrongEmployees Are Eligible For The Following Time Off Benefitsbr/strongulliVacation - up to 120 hours per calendar year /liliSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year /liliHoliday pay, including Floating Holidays - up to 13 days per calendar year /liliWork, Personal and Family Time - up to 40 hours per calendar yearbr/li /ulFor additional general information on company benefits, please go to: 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.brJohnson 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.br#J-18808-Ljbffr

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