At a Glance
- Tasks: Write and coordinate clinical documents in a collaborative team environment.
- Company: Join a leading pharmaceutical company focused on innovative medical writing.
- Benefits: Remote work options, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in the field of immunology while developing your writing skills.
- Qualifications: Degree in a scientific discipline and 0-2 years of relevant experience required.
- Other info: Dynamic role with mentorship and excellent career advancement opportunities.
The predicted salary is between 36000 - 60000 Β£ per year.
- 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.
- You will be responsible for:
- Writes and coordinates basic clinical documents such as, but not limited to, Phase 1 protocols, Phase1/2 CSRs, table of studies, narratives, and initial IBs.
- Writes, contributes to, and/or coordinates low to medium complexity clinical and regulatory documents such as, but not limited to, 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, with some mentorship from functional management and clinical team, as needed.
- In accordance with experience level:
- guides or trains cross-functional team members on processes and best practices.
- leads early- or late-stage compound writing teams with supervision, as required.
- 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 (eg, project kick-off and review meetings, study team meetings, Global Program Team meetings).
- Completes all time reporting, training, and metrics database, and project tracking updates as required in relevant company systems.
- Maintains and applies knowledge of industry, company, and regulatory guidelines.
- Education:
- A university/college degree in a scientific discipline is required.
- An advanced degree (eg, Masters, PhD, MD) is preferred.
- A minimum of 2 years of relevant pharmaceutical/scientific experience is required.
- A range of 0 to 2 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, both in project and process management as well as in 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.
#J-18808-Ljbffr
Analyst II, Medical Writing, Immunology employer: Johnson & Johnson
Contact Detail:
Johnson & Johnson Recruiting Team
StudySmarter Expert Advice π€«
We think this is how you could land Analyst II, Medical Writing, Immunology
β¨Tip Number 1
Network like a pro! Reach out to folks in the industry, join relevant groups on LinkedIn, and donβt be shy about asking for informational interviews. You never know who might have the inside scoop on job openings!
β¨Tip Number 2
Prepare for those interviews! Research the company and its projects, especially in immunology. Be ready to discuss how your skills align with their needs and show off your knowledge of regulatory guidelines.
β¨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online platforms. Focus on articulating your experience in medical writing and how you can contribute to their team.
β¨Tip Number 4
Apply through our website! Itβs the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Analyst II, Medical Writing, Immunology
Some tips for your application π«‘
Tailor Your Application: Make sure to customise your CV and cover letter for the Analyst II role. Highlight your relevant experience in medical writing and any specific projects that align with the responsibilities listed in the job description.
Showcase Your Skills: Donβt forget to emphasise your strong communication skills and attention to detail. We want to see how you can contribute to our team, so include examples of how you've successfully managed projects or collaborated with others in the past.
Follow the Guidelines: Adhere to the application guidelines provided on our website. This includes formatting your documents correctly and ensuring you include all necessary information. A well-structured application shows us you pay attention to detail!
Be Yourself: Let your personality shine through in your application. Weβre looking for someone who fits well with our team culture, so donβt be afraid to show us what makes you unique and why youβre passionate about medical writing in immunology.
How to prepare for a job interview at Johnson & Johnson
β¨Know Your Documents
Familiarise yourself with the types of clinical documents you'll be working on, like Phase 1 protocols and CSRs. Being able to discuss these confidently will show your understanding of the role and impress the interviewers.
β¨Showcase Your Team Spirit
Since this role involves working in a team environment, be ready to share examples of how you've collaborated with others in the past. Highlight any experiences where you led or contributed to cross-functional meetings, as this will demonstrate your ability to work well with diverse teams.
β¨Demonstrate Attention to Detail
Prepare to discuss how you ensure accuracy in your work. You might want to mention specific strategies you use for document QC or how you manage timelines and schedules. This will reassure them that you can handle the meticulous nature of medical writing.
β¨Brush Up on Regulatory Knowledge
Make sure you're up to speed on ICH requirements and other regulatory guidelines relevant to the role. Being able to talk about these during your interview will show that you're proactive and serious about adhering to industry standards.