Associate Director, Medical Writing

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 primary purpose of this position is to develop and set timelines and resources needed to develop study related documents, drive the process for development, management and approval of clinical study related documents and regulatory submissions, and to serve as the primary author of clinical study documents (study protocols, CSRs, etc).

Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

* Responsible for establishing strategies for document authoring, contributing strategically and scientifically at the project and/or study team level, managing vendors and external writers with regard to document quality, and developing medical writing timelines, processes, and working standards.
* Working with Clinical development and Cross functional teams, facilitating development of clinical study synopsis and clinical protocols, amendments, CSRs and related study documents.
* Working with Clinical development and cross functional team to determine document authoring resource needs, proactively identifies issues and solutions, and sets timelines and processes.
* Manages vendors and external writers with regard to document quality; provides guidance to external writers on company standards and style and industry best practices for regulatory writing.
* Ensures clinical study and regulatory documents are in compliance with company standard operating procedures (SOPs) and applicable health authority guidance and regulations.
* Ensures key messages are clear and consistent within and across documents.
* Contributes strategically and scientifically at the project team level.
* Contributes to formation of key messages in consultation with functional area experts.
* Advises project and study teams regarding regulatory requirements and ICH guidance for clinical documents.
* Develops clinical and regulatory writing timelines, processes, and working standards; ensures company SOPs, templates, style guides, etc, are aligned with industry best practices.
* Contributes interdepartmentally to Clinical/Medical, Drug Safety, and R&D departments as needed.
* Provide management support for activities with outside vendors and business partners, as required.
* Working with Clinical and Regulatory Lead, prepares Clinical Development Strategy Documents for clinical development projects.
* Depending on experience and need, may be assigned other clinical, regulatory or operational projects within the Clinical Department.

Supervisory Responsibilities:
This position does not have supervisory responsibilities.

Interaction:
The incumbent works with internal teams and vendors.

Education and Experience:
* Bachelor's Degree with a major in an analytical, data-oriented field of study from an accredited college or university is required; advanced degree is preferred.
* Minimum 5-7 years of relevant experience in Clinical Development, Clinical Writing, Medical Writing or a related function with pharmaceutical or biological products.

Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below 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:
* Knowledge of clinical development required; knowledge of nonclinical, clinical pharmacology, biostatistics and CMC regulatory desirable.
* Knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly; familiarity with clinical, regulatory, medical and scientific terminology is necessary.
* Ability to develop and track a variety of diverse project budgets and identify key performance indicators, in a fast-paced, changing environment.
* Proficiency using Microsoft Word, Excel and PowerPoint.
* Excellent oral and written English communication skills.
* Ability to present scientific and technical information in a concise and clear manner.
* Experience with ex-US regulatory submissions is a plus.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The on-site setting is consistent of a typical pharmaceutical office environment with production areas, offices, and cubicles. This role can be performed remotely.

• 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.