Associate Director, Medical Writing, Plasma-Derived Therapies応募後で応募 求人ID R0040671 掲載日 08/19/2021 Location:Boston, Massachusetts
Associate Director, Medical Writing, Plasma-Derived Therapies
- Responsible for medical writing activities for a program or multiple programs within a therapeutic area depending on the scope and stage of clinical development and may or may not have direct reports.
- Provides strategic direction to cross-functional project teams to ensure that clinical regulatory documents (eg, investigators' brochures, study protocol and amendments, study reports, marketing authorization submission documents) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements. Provides direction and leadership to other writers to ensure the timely delivery of high-quality documents that are scientifically rigorous, logically organized, and which provide accurate data presentation and interpretation.
- Responsible for a non-project related activities (eg, subject matter expert for a process), and generally leads or participates on departmental or cross-functional initiatives designed to establish best practices and efficient cross-functional collaboration.
- Contributes to therapeutic area project teams as the medical writing expert for regulatory submission documents. Collaborates with all Takeda regions to ensure a medical writing regulatory document strategy is created and executed upon for all products within area of responsibility.
- Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
- Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications.
- Coordinates the activities of Takeda employees, contract employees and vendors (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues.
- Within designated therapeutic area, manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements, as well as Takeda requirements and processes across development programs.
- Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards). As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree is required.
- At least 10 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company is required.
- Experience with Plasma-Derived Therapies
- Experience as lead writer for key documents included in major US and/or international regulatory submissions required.
- Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred.
- Demonstrated ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team.
- Demonstrated ability to independently lead the development, review, and approval of all clinical document types (ie, those typically developed by MW) and the ability to identify any new or unique document types which may require a different approach.
- Excellent project management skills including in depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups.
- Working knowledge of current global regulatory requirements/guidelines applicable to clinical research (eg, GCP).
- Working knowledge of the regulatory guidance(s) regarding content for various document types including, but not limited to, ICH E3 (CSRs), ICH E6 (IBs), ICH M4, ICH E2E, EMA guidance on RMPs).
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Takeda U.S. Vaccine Requirement:
Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.