Manager, Regulatory Medical Writing, X-TA
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Job Location:
High Wycombe - UK
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Medical Affairs GroupJob Sub Function:
Medical WritingJob Category:
ProfessionalAll Job Posting Locations:
High Wycombe Buckinghamshire United KingdomJob Description:
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. Learn more at are searching for the best talent for a Manager Regulatory Medical Writing to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located High Wycombe UK; Leiden Netherlands; Neuss Germany; Paris France; or Beerse Belgium. The position is Hybrid (3 days onsite weekly). Remote work options may be considered on a case-by-case basis and if approved by the company.
Are you ready to join our team Then please read further!
You will be responsible for:
- Preparing and finalizing all types of clinical documents.
- Leading in a team environment. Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy timing scheduling and tracking.
- Leading or setting objectives for others on team projects and tasks eg leading process working groups.
- Guiding or training cross-functional team members on processes and best practices.
- Potentially leading project-level/submission/indication writing teams.
- Proactively providing recommendations for departmental process improvements.
- If a lead writer for a program: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
- Actively participating in medical writing and cross-functional meetings.
- Maintaining knowledge of industry company and regulatory guidelines.
- Coaching or mentoring more junior staff on document planning processes content and provide peer review as needed; overseeing the work of other medical writers external contractors and document specialists supporting a project.
- Interacting with senior cross-functional colleagues to strengthen coordination between departments.
- May be representing Medical Writing department in industry standards working groups.
Qualifications /Requirements:
- University/college degree required. Masters or PhD preferred.
- At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required!
- Experience of multiple therapeutic areas preferred.
- Attention to detail.
- Excellent oral and written communication skills are pivotal to engage in cross-functional discussions. English fluency required.
- Expert project/time management skills.
- Strong project/process leadership skills.
- Ability to recognize how to best interpret summarize and present statistical and medical information to ensure quality and accuracy of content.
- Able to resolve complex problems independently.
- Demonstrate learning agility.
- Able to build and maintain solid and positive relationships with crossfunctional team members.
- Solid knowledge and application of regulatory guidance documents such as ICH requirements.
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):
United Kingdom - Requisition Number: R-044899
Netherlands Germany France Belgium- Requisition Number: R-045504
Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.
Benefits
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. For additional general information on company benefits please go to: qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform important job functions and to receive other benefits and privileges of employment. Please contact us to request accommodations.
#LI-Hybrid
#LI-Remote
Required Skills:
Clinical Study Reports Medical Writing Project Team Leadership Regulatory Documents Submission ManagementPreferred Skills:
Business Writing Clinical Research and Regulations Clinical Trials Operations Coaching Collaborating Copy Editing Data Synthesis Industry Analysis Medical Affairs Medical Communications Process Improvements Proofreading Quality Validation Standard Operating Procedure (SOP) Tactical Planning Technical CredibilityRequired Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
