Senior Director, Medical Writing and Transparency
Category: Research & Development | Country: United States | State: California | City: Palo Alto | Type: Regular, Full Time | Job ID: 4234
Same Job Available In Two Locations
Palo Alto, California, United States
Philadelphia, Pennsylvania, United States
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.
As a key leadership position within the R&D organization, this role is responsible for providing strategic leadership to and managerial oversight of the Medical Writing and Transparency department.
This leader is responsible for the provision of medical writing and disclosure / transparency activities to support the clinical development, clinical safety and regulatory requirements of our clinical programs. He / she is accountable for the efficient preparation and delivery of high-quality, strategically aligned, scientifically credible medical writing deliverables. He or she is also accountable for the establishment of a messaging strategy across a program of work, for the provision of strategic input into the development of clinical 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 (i.e., regulatory authority) in a compelling manner with accuracy and consistency.He / she is accountable for ensuring compliance with applicable transparency / disclosure regulations, and is accountable for mitigating risk associated with medical writing and transparency / disclosure processes by establishing and maintaining Best Practices and SOPs.
This role has global responsibilities, including global stakeholders, participation in global teams and interaction with regulatory agencies in multiple regions. This role also has line management responsibilities.
Ensures that the messaging and communication strategy within the clinical program (ie, development plans, briefing books, milestone submissions, responses to HA questions) is effective and underpins successful clinical development.
- Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents.
- 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.
- Analyses proposed strategy 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.
Ensures Jazz compliance with clinical trial disclosure and transparency requirements
- Liaises with senior management across the organization to ensure alignment of strategy for public disclosure of clinical trial data as per global regulations.
- Minimizes company risk through the establishment and maintenance of transparency and disclosure Best Practices and SOPs.
- Keeps abreast of current transparency and disclosure requirements, and represents Jazz in relevant industry association trial disclosure subcommittees.
Manages Medical Writing and Transparency department and staff.
- Attracts and retains talent
- Coaches, trains and mentors staff, thereby contributing to successful clinical development, product registration in key regions and commercialization of new compounds, including important lifecycle management work.
- Accountable for the quality of medical writing deliverables from direct reports and ensures work adheres to departmental procedures / practices, and industry / international standards.
- Accountable for ensuring appropriate medical writing and transparency support for the clinical programs including forecasting, budgeting, resource planning and resource allocation
- Develops and drives department operating model and outsourcing strategy
- Accountable for tracking medical writing and disclosure budget, and managing spend against forecast.
Responsible for establishing, developing and maintaining collaborative relationships with medical writing and transparency vendors to ensure effective, productive and professional working relationships – and delivery of high quality work products for our clinical programs.
- Accountable for managing bid defences, vendor agreements and contracts.
- Negotiates with vendor to determine roles, responsibilities, processes and mutual expectations.
- Responsible for vendor oversight and governance.
Additional responsibilities for:
- Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks.
- Responsible for continual improvement of in-house medical writing and transparency activities.
- Provides expert writing and transparency support to other functions where required
Required Knowledge, Skills, and Abilities
- Minimum of 8 years of medical writing experience within the biopharmaceutical industry or contract research organization and at least 3 years of experience in a supervisory role.
- 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 and their associated regulatory requirements.
- A comprehensive understanding of medical writing processes, standards, and issues.
- Demonstrated track record in cross-functional, multicultural, and international clinical development teams.
- Excellent written and oral communication skills and demonstrated coaching and problem-solving abilities
- Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
- Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
- Knowledge of eTechnology related to regulatory submission activities (eg, eCTD).
Other Valuable Experience:
- Ability to think strategically; demonstrated negotiating skills and resourcefulness.
- Strong interpersonal skills; proven track record of staff management and effective leadership.
- 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.
- Can manage uncertainty and shifting priorities and timelines.
- Demonstrates learning agility.
- 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 organisational and time management skills.
- Attention to detail.
Required/Preferred Education and Licenses
- Post-graduate qualifications in a scientific discipline
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
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.