Celgene Senior Manager, Aggregate Safety Reporting in Summit, New Jersey
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.
Celgene is hiring a Senior Manager, Aggregate Safety Reporting to join our Global Drug Safety and Risk Management team in Summit, NJ. In this role, you will be responsible for providing Periodic Safety Update Reports, Development Safety Update Reports, Addendum Reports and US Periodic Safety Reports in publishing-ready format. The ideal candidate for this role is a critical thinking, highly skilled writer with deep knowledge of FDA and EMA regulations and guidelines.
Responsibilities include, but are not limited to, the following:
Following a project schedule, author and create aggregate safety reports (ASR) as assigned, using the appropriate template.
Provide US Periodic Safety Reports in Periodic Benefit Risk Evaluation Report (PBRER) format
Provide documents according to approved templates.
Update and edit aggregate safety reports during review cycles.
Ensure thorough review of documents (both self-review and peer review) for data accuracy, correct use of grammar and consistency with the Celgene Style Guide prior to sharing with ASR team for review.
Ensure consistency of Development Safety Update Reports (DSUR) and Periodic Safety Update Reports (PSUR) 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 and 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 Global Drug Safety and Risk Management and other departments as needed.
Raise any concerns regarding content or process to the Senior Director, Global Drug Safety and Risk Management in a timely manner.
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 or biotech writing, preferably in PV writing
Experience with safety databases (ARISg or similar) and their output
Expertise in medical or scientific writing
English language expert; strong writing, editing and proofreading skills
Excellent written and oral communication skills
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
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
Knowledge of interpretation and presentation of aggregate safety data
Knowledge of commercial drug environment
Clinical knowledge of therapeutic area patient populations and drug classes
Ability to interpret, analyze and clearly present scientific & technical data (oral & written)
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.