Celgene Senior Manager, Aggregate Safety Reporting in Summit, New Jersey

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

GDSRM, Senior Manager, Aggregate Safety Reporting (ASR) Medical Writer (Grade 10)

Summary:

Reporting to the Senior (Sr) Director, Global Drug Safety & Risk Management (GDSRM), Aggregate Safety Reporting (ASR), the primary role of the ASR Sr Manager, Medical Writer is to provide formatted Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Addendum Reports and US Periodic Safety Reports (PSRs) in publishing-ready format.

Responsibilities include, but are not limited to, the following:

  • Author and create ASRs (PSURs, DSURs, Addendum reports and US PSRs) as assigned, using the appropriate template

  • Provide PSURs in Periodic Benefit Risk Evaluation Report (PBRER) format

  • Provide documents according to approved templates

  • Follow the project schedule for each report

  • Update and edit ASRs during review cycles

  • Ensure thorough review of documents (both self-review and peer review) for data accuracy, consistency, correct use of grammar and consistency with the Celgene Style Guide prior to sharing with ASR team for review

  • Ensure consistency of DSURs and PSURs for the same compound for the same reporting period

  • Review of previous DSURs, PSURs, and PSUR assessment reports to ensure consistency of content

  • Attend training as appropriate/assigned

  • Attend report Kick off, Strategy and Comment Resolution meetings

  • Support other Medical Writers’ activities as needed

  • Liaise with ASR team members as needed

  • Liaise with other members of GDSRM and other departments as needed

  • Raise any concerns regarding content or process to the Sr Director in a timely manner

Qualification/Experience Required:

  • Minimum of PharmD, MS, or the equivalent combination of relevant education and professional experience (BS with appropriate experience will be considered)

  • Minimum of five years relevant experience in pharma/biotech writing, preferably in PV writing

  • Experience with safety databases (ARISg or similar) and their output

  • Expertise in Medical and/or Scientific Writing

Knowledge/Skills/Competencies Required:

  • English language expert; strong writing, editing and proofreading skills

  • Excellent communication skills (written & oral)

  • Familiarity with AMA style guide

  • Ability to integrate, analyze, interpret and summarize data from a variety of sources in a clear and concise manner.

  • Demonstrated high degree of independence with effective presentation, proofreading, and interpersonal skills to ensure a team-oriented approach

  • Understanding of medical terminology and statistical methods

  • Strong proficiency in MS Word, Excel, Outlook, PowerPoint

  • Experience with the use of SharePoint

  • Experience with the use of document management systems

  • Ability to demonstrate a familiarity with principles of PV and to interpret and present clinical and post marketing data

  • Ability to work as part of a team, multi-task and meet internal and regulatory deadlines

  • Strong knowledge of clinical trials & drug development

  • Strong knowledge of FDA and EMA regulations and guidelines, as well as ICH guidelines

  • Appreciation of the global safety environment, international regulations & guidance documents

  • Understanding of safety data capture in CT & PM settings

  • Familiarity with safety database output, preferably ARISg and Business Objects

  • Knowledge of interpretation & presentation of aggregate safety data

  • Knowledge of commercial drug environment

  • Clinical knowledge of therapeutic area patient populations & drug classes

  • Meticulous attention to detail

  • Critical thinker

  • Organization and planning skills

  • Ability to interpret, analyze and clearly present scientific & technical data (oral & written)

  • Ability to work on a global multifunctional team

  • Strong competence in information analysis

  • Able to work with minimal supervision

  • Ability to thrive in a global matrix environment

  • Confidence in making decisions

  • Sense of urgency

#LI- POST

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.