Associate Director, Medical Writing
Job Description
Description
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.
At Pacira Pharmaceuticals, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical and chronic pain market, coupled with our passion for delivering improved patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.Pacira Pharmaceuticals currently has an opening for a Director, Medical Writing.
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).
- 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.
The qualified individual will possess the following:
- 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.
- 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.
Benefits:
- 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
The base pay range for this role is $132,000 per year to $170,000 per year.
The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.
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.
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