Medical Writing, Clinical Transparency Scientist

About Astellas

Astellas is a global life sciences company committed to turning innovative
science into VALUE for patients. We provide transformative therapies in disease
areas that include oncology, ophthalmology, urology, immunology and women's
health. Through our research and development programs, we are pioneering new
healthcare solutions for diseases with high unmet medical need. Learn more at
Astellas.com [https://www.astellas.com/en].

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace
new ideas, and aren't afraid to take intelligent risks. People who act with
unwavering integrity and are deeply committed to making a tangible impact.

Purpose and Scope:

* Execute the clinical transparency (i.e., registration, updates and/or results
disclosure) or public disclosure processes for assigned studies and/or assets
conducted by Astellas globally.
* Create documents (i.e., plain language documents, redacted documents, public
disclosure plan) necessary to support clinical transparency and public
disclosure.
* Demonstrate proficiency in clinical transparency or public disclosure
activities.
* Contribute toward the establishment and refinement clinical transparency or
public disclosure processes while ensuring adherence to all applicable laws,
regulations, industry guidance and corporate position.
* Monitor global regulatory requirements and the industry environment affecting
clinical transparency or public disclosure and communicate changes to fellow
team members.

Responsibilities and Accountabilities:

* Prioritizes, and performs the day-to-day operations of Clinical Transparency
or Public Disclosure, ensuring the timely completion, review and approval of
registration, updates and results disclosure activities or public disclosure
strategy plans and public disclosure tracking mechanisms for studies and
assets conducted globally.
* Makes appropriate decisions regarding the applicability and timing of
clinical transparency or public disclosure activities according to national
laws, regulations, industry guidance and corporate position.
* Manages the review and approval process for Clinical Transparency (clinical
trial registrations, updates and results disclosures) and related documents
(plain language and redacted documents) or public disclosure strategy plans
and public disclosure tracking mechanisms, including communication with
partner companies or collaborators.
* Facilitates periodic review of active registrations or public disclosure
strategy plans to ensure records are updated or verified as required.
* Uses appropriate problem solving to determine escalation of issues to
management.
* Addresses inquiries related to clinical transparency and related documents or
public disclosure activities.
* Interacts and collaborates across various departments and management levels
within Astellas to ensure open and effective communication.
* Provides feedback to clinical transparency or public disclosure leadership
resulting from new and updated transparency requirements. Ensures compliance
with evolving clinical transparency or public disclosure requirements,
including retrospective review and work as necessary.
* Contributes toward the continuous improvement of global clinical transparency
or public disclosure processes, procedures, and standards.
* Establishes and maintains global working relationships.

Qualifications

Required Qualifications:

* Bachelor’s Degree, or equivalent experience required.
* Proficient organizational skills and high attention to detail.
* Self-directed and motivated, with ability to work without significant direct
supervision, asking questions when necessary.
* Ability to manage multiple tasks and readily switch activities to accommodate
priority needs.
* Proficient computer skills, including experience with MSWord and Excel.
* Healthcare professional background preferred.

Preferred Qualifications:

* 2 years pharmaceutical industry experience in writing content for Clinical
Transparency purposes.
* Clinical trials experience including study management, statistics, medical
writing and / or data management preferred.
* Working knowledge of clinical drug development and clinical trial protocols
preferred.
 

Working Environment:

At Astellas we recognize the importance of work/life balance, and we are proud
to offer a hybrid working solution allowing time to connect with colleagues at
the office with the flexibility to also work from home. We believe this will
optimize the most productive work environment for all employees to succeed and
deliver. Hybrid work from certain locations may be permitted in accordance with
Astellas’ Responsible Flexibility

What awaits you at Astellas? 

* Global collaboration: Become part of a connected global business of
like-minded life science leaders, all dedicated to improving patients' lives
worldwide. 
* Real-world patient impact: Contribute to transformative therapies that reach
patients around the world, knowing your work makes a difference every day.
* Relentless Innovation: Join a company at the forefront of scientific
breakthroughs, where you'll have the opportunity to shape the future of
healthcare. 
* A Culture of Growth: Chart your own course within a supportive environment
that values your contributions, champions your development, and empowers you
to pursue your passions. 

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do. 

Behaviors: We come together as ‘One Astellas’, working with courage and a sense
of urgency. We are outcome focused and consistently take accountability for our
personal contribution.