Biotechnology, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
Available to sit in Philadelphia, PA or Palo Alto, CA.
The Associate Director, Medical Writing, is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, safety and regulatory requirements of a clinical program. He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of development plans and submission plans, and for analyzing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency.
The incumbent will ensure that strategically aligned communication points are conveyed in medical writing deliverables and that the communication points are consistent across program documentation. He / she will mitigate risk associated with medical writing and disclosure processes by establishing and maintaining Best Practices and SOPs.
This role has global responsibilities, including participation in global teams and interaction with regulatory agencies in multiple regions.
Drives and develops the messaging strategy within the clinical program to ensure effective communication (ie, development plans, submissions, briefing books, risk management plans, responses to HA questions) underpins successful clinical development.
Interfaces with Therapeutic Area Heads, Clinical Program Directors, Biostatistics and Safety Physicians to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process.
Leads cross-functional teams to develop a messaging strategy across a program of work (ie, building a clinical submission or a data disclosure plan)
Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency.
Critiques ability of product strategy (ie, submission plans) to deliver on business objectives or meet regulatory needs, and identify where new, additional or alternative arguments are needed.
Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study level documents to final program level deliverables (ie, regulatory submission or publication of key journal articles for a publication plan).
Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents.
Builds convincing clinical or regulatory arguments using logic, analogy and therapeutic area science. Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents.
Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data.
Liaises with functional groups within and external to R&D to ensure independent and interdependent communication needs and strategies are considered during document development (eg, communicating data in a CSR and regulatory documents to support NDA and Advisory Committee positioning)
Accountable for medical writing deliverable quality and ensures work on assigned projects adheres to departmental procedures / practices, and industry / international standards
Drives the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables.
Additional responsibilities for:
The efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines
Program forecasting, budgeting, and provides support to MWD management in resource planning
Collaboration and strategic partnership with key stakeholders to ensure understanding of program strategy and the nature of medical writing services required to deliver on company objectives
Building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship (defines the scope of work to be outsourced, and is responsible for medical writing vendor oversight on the outsourced deliverables)
BA/BS or higher and at least 6 years of writing experience in the pharmaceutical industry
Exceptional English language skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
A solid understanding of the clinical development process, including the documents that are required at each stage
Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates
Excellent written and oral communication skills and demonstrated coaching and problem-solving abilities Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
Other Valuable Experience:
Ability to think strategically; demonstrated negotiating skills and resourcefulness. Demonstrated ability to manage several projects simultaneously
Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
Strong influencing skills, able to lead without formal authority
High degree of influencing skills in shaping and developing content and wording
Demonstrated ability to work collaboratively; multicultural sensitivity, builds positive and productive relationships, seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions / proposals
Successful track record of leading complex clinical / regulatory writing projects. Demonstrated ability to make decisions even in the absence of complete information
An excellent understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP)
Excellent organizational and time management skills. Attention to detail
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
Internal Number: 4190
About Jazz Pharmaceuticals
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.