Sr. Manager Medical Information
Compensation: $216,880.00 - $216,880.00 /year *
Employment Type: Full-Time
Industry: Non-Executive Management
Loading some great jobs for you...
Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.
The Senior Manager, Medical Information will be responsible for providing accurate, timely, fair-balanced medical information in response to medical inquiries from external customers (healthcare professionals and consumers) as well as internal customers (corporate, medical, and sales teams) working alongside the medical communications team. He/she will ensure compliance with all relevant SOPs, and FDA regs/guidances, adverse event and product complaint handling and become an expert in our product and corresponding therapeutic area, with a focus on drug safety.
The Senior Manager will update and create response documents as needed after conducting a literature search, and choose appropriate information for inclusion, will assist in medical, legal, and regulatory review of submissions, and will coordinate with the medical information vendor as needed. As a product expert with a focus on drug safety, the Senior Manager will act as liaison to the Pharmacovigilance team and assist with development and presentation of training materials.
* Write, review, and maintain/update/retire standard and custom response letters, global core response documents, FAQs and answer medical information queries, as needed
* Perform literature searches; and in-depth research, analysis and interpretation of medical data
* Develop/deliver med info training for internal teams and med info vendor
* Assist in development and review of medical communications materials for medical field teams (eg decks and summary documents)
* Assist in the creation of metrics and performance reports to Senior Management
* Assist the Director, Pharmacovigilance in obtaining followup information on adverse event reports that are received through Medical Information queries
* Perform QA/QC of med info vendor as needed
The qualified candidate will possess the following:
* Pharmacist, or biomedical graduate degree (MS, PharmD or PhD in relevant scientific discipline)
* At least 3 years relevant pharmaceutical industry experience required
* Medical, legal, and regulatory review experience
* Experience with preparation of individual case safety reports
* Proven ability to perform in-depth research, analysis and interpretation of medical data and assemble evaluated information into an accurate, comprehensive and concise response document
* Must have working knowledge of the applicable FDA regulations/guidances
* Global experience preferred
* Proficient in conducting medical literature searches
* Proficient in medical writing for medical information response documents
* Ability to summarize medical literature/accurately and appropriately (creating medical information response documents that are accurate, current, scientifically fair- balanced, and of high quality).
* Prior experience working in IRMS is strongly preferred
* Customer Focus - is dedicated to meeting the expectations and requirements of internal and external customers
* Ability to prioritize tasks
* Flexibility in response to changing needs and competing demands
* Solutions oriented
* Ability to work independently and as a team player
* Experience in working with cross-functional, multi-cultural teams
* Highly organized and demonstrates consistent attention to detail and quality
* Strong verbal and written communication skills
* Good interpersonal relationship and people skills
Equal Opportunity Employer/Veterans/Disabled* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
Loading some great jobs for you...