Associate Director, Medical Writing
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: August 17, 2019
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
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
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
This role has global responsibilities, including participation in
global teams and interaction with regulatory agencies in multiple
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
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
* Responsible for ensuring that statements included in the
deliverables are accurate and supported by appropriate data.
* Sets program-level standards (eg, style convention)
* 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
* BA/BS or higher and at least 6 years of writing experience in the
* 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
OTHER VALUABLE EXPERIENCE:
* Ability to think strategically; demonstrated negotiating skills
* Demonstrated ability to manage several projects
* Ability to analyze critically and synthesize complex scientific
information from a range of scientific disciplines and clinical
* Strong influencing skills, able to lead without formal
* 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
* Demonstrated ability to make decisions even in the absence of
* An excellent understanding of all aspect of ICH-GCP; keen insight
on external clinical publication practices and standards (ICMJE,
* Excellent organisational 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.
Apply for this job onlineApply
Email this job to a friendRefer
Sorry the Share
Keywords: Jazz Pharmaceuticals, San Francisco , Associate Director, Medical Writing, Executive , Palo Alto, California
Didn't find what you're looking for? Search again!