Senior Manager Medical Information

About Pacira

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.

Why work with us?

Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let's pursue excellence together.

Summary:

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.

Essential Duties & Responsibilities:

• Write, review, and maintain/update/retire standard and custom response letters, global core response documents, FAQs and related medical communications materials

• Working with Pharmacovigilance, incorporate relevant safety information into medical information standard and ad hoc responses

• Perform literature searches; and in-depth research, analysis and interpretation of medical data

• Assist the Director, Pharmacovigilance in obtaining detailed followup information on adverse event reports that are received through Medical Information queries

• Develop/deliver med info training for internal teams and med info vendor

• Assist in development 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

• Perform QA/QC of med info vendor as needed

Supervisory Responsibilities:

This position does not have supervisory responsibilities.

Interaction:

The incumbent works closely with internal (corporate, medical, and sales teams) and external customers

Education and Experience:

• 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

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and work independently, planning their time to meet both short-term and long-term objectives. The requirements described above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knowledge, Skills, and Abilities:

• 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

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse. Will need to lift and move items weighing up to 40 pounds.

Work Environment:

The work setting is consistent of a typical pharmaceutical office environment with production areas, offices, and cubicles.

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program
• Mental Health Resources
• Disability Coverage
• Life insurance
• Critical Illness and Accident Insurance
• Legal and Identity Theft Protection
• Pet Insurance
• Fertility and Maternity Assistance
• 401(k) with company match
• Flexible Time Off (FTO) and 11 paid holidays
• Paid Parental Leave

EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.