Senior Manager Medical Writer - Aggregate Safety Reporting

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Reporting to the Associate 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 ASR management 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

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1520305_EN

Updated: 2020-03-18 00:00:00.000 UTC

Location: Summit,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com