Overview 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 Job FunctionMedical Affairs GroupJob Sub FunctionMedical WritingJob CategoryProfessionalAll Job Posting Locations: Bilbao, Vizcaya, Spain; Issy-les-Moulineaux, Hauts-de-Seine, France; Leiden, South Holland, Netherlands; Norderstedt, Schleswig-Holstein, Germany
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. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Note: this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. You may apply to one or more postings; applications are considered as a single submission. This 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.
We invite candidates from any location to apply. Specific cities listed in the Locations section are examples only and do not limit your application.
Role and Locations We are searching for the best talent for Associate Director, Regulatory Medical Writing - Oncology.
Responsibilities
Able to function as a lead writer on any compound independently.
Lead in setting functional tactics/strategy and lead project-level strategy (eg, submission team, integral program team).
May represent therapeutic area (TA) head at high-level meetings and has some independent decision-making authority.
Able to write and coordinate complex documents within and across TAs independently.
Contribute to and champion internal standards, regulatory, and publishing guidelines; contribute to and champion improvement of internal systems, tools, and processes.
Able to lead process working groups and oversee the work of external contractors.
May have additional major responsibility with supervision: cross-functional, cross-TA, or cross-J&J; initiative/collaboration; larger organizational responsibility (eg, manage a subset of TA).
If a people manager: manages a team of internal medical writers (direct reports) and is accountable for the quality of deliverables and compliance of direct reports.
Participates in resource management and hiring decisions.
Lead compound/submission/indication/disease area writing teams independently.
Directly leads or sets objectives for others on team projects and tasks; leads Medical Writing process groups or Communities of Practice.
Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
Establishes and drives document timelines and strategies independently.
Guides or trains cross-functional team members on processes and best practices; coaches or mentors more junior writers.
Proactively identifies and champions departmental process improvements; may develop and present best practices or innovations.
May lead cross-functional or cross-J&J; process improvement initiatives; leads discussions in MW and cross-functional meetings as appropriate.
Maintains and disseminates knowledge of industry, company, and regulatory guidelines; completes time reporting, training, metrics, and project tracking updates as required in relevant systems.
Mentors more junior staff on document planning, processes, content, and peer review as needed; interacts with senior cross-functional colleagues and external partners to strengthen coordination between departments.
May represent MW in industry standards working groups; as a MW lead, serves as the primary point of contact for MW activities for the cross-functional team (eg, clinical).
People Management (if applicable)
Supervises/manages and is accountable for direct reports; sets objectives and goals.
Provides performance oversight and development; regularly meets with direct reports to resolve issues and ensure appropriate development.
Ensures adherence to policies, participates in hiring, onboarding, talent development discussions, goal-setting, performance reviews, and compensation planning.
Qualifications / Requirements
A university/college degree in a scientific discipline is required.
An advanced degree (eg, Masters, PhD, MD) is preferred.
At least 10 years of relevant pharmaceutical/scientific experience is required.
At least 8 years of relevant clinical/regulatory medical writing experience is required.
Experience in project management and process improvement is required.
If a people manager: at least 2 years of people management experience is required.
Strong ability to interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Resolves complex problems independently; advanced knowledge of regulatory guidance documents such as ICH requirements.
Excellent oral and written communication skills; attention to detail; expert time management; ability to build relationships across functions.
Expert project management and leadership skills; strong ability to influence, negotiate, and manage change.
Ability to delegate to junior writers; lead by example and act with integrity; ability to adapt to rapidly changing challenges.
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