Analyst II, Medical Writing, Immunology

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

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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.

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. 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.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

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 States- Requisition Number: R-032561

Belgium & Netherlands - Requisition Number: R-033141

United Kingdom- Requisition Number: R-033139

Switzerland- Requisition Number: R-033142 

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Purpose:

• 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.

Qualifications / Requirements:

• Education: A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.

Skills/Experience:

• A minimum of 2 years of relevant pharmaceutical/scientific experience is required.
• A range of 0 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, 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.