Analyst II, Regulatory Medical Writing - Oncology

We are recruiting for an Analyst II - Oncology to join the Regulatory Medical Writing team to support our [Insert TA] therapeutic area. This position is open globally and may be located in North America (eg, Spring House, PA, Raritan, NJ, Titusville, NJ, or Canada), Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy, Poland, Bulgaria or Switzerland), or other countries. 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!

At 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.

Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension, and cardiovascular and metabolic diseases.

Key Responsibilities:

Depending on your experience, your responsibilities will cover a range of activities including:

• • Prepare and finalize clinical documents such as, but not limited to, clinical study reports, investigator's brochures, protocols, summary documents, briefing books, and regulatory responses.
• • Perform document QC, generate list of abbreviations and references, conduct literature searches, and other basic tasks.
• • Participate in and may lead cross-functional document planning and review meetings.
• • Interact with peer writers and colleagues from other departments.
• • If a lead writer for a compound or document: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
• • Learn and adhere to SOPs, templates, best practices, policies, and Medical Writing Style Guide.
• • Acquire, maintain, and apply knowledge of the industry, company, and regulatory guidelines.

Qualifications

Education:

• University/college degree required. Masters or PhD preferred.

Experience and Skills:

We would value a colleague with these qualities:

• At least 2 years of relevant pharmaceutical/scientific experience; previous regulatory medical writing experience is preferred.

• Ability to learn and recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in document types under supervision.

• Attention to detail.

• Strong oral and written communication skills.

• Emerging leadership skills, both in time management as well as in project/process management.

• Able to resolve basic problems independently and complex problems under supervision.

• Demonstrate learning agility.

• Able to build solid and positive relationships with cross-functional team members.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & 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.

Client-provided location(s): Spring House, PA, Titusville, NJ

Job ID: Johnson&Johnson-2406204376W

Employment Type: OTHER

Posted: 2024-08-07T12:37:21