Technical Writer

Vor 3 Tagen

Basel, Schweiz Takeda Pharmaceutical Vollzeit

**About the role**:
Takeda’s Neuchatel Manufacturing Sciences/Quality Compliance teams are looking for a highly motivated Technical Writer.

The role is expected to have a solid understanding of regulatory guidelines as well as background of biopharma processes including related GMP requirements.

**How you will contribute**:
**Your mission**

As Technical writer you will report directly to the Manufacturing Sciences Manager and be responsible for supporting any submissions for Neuchâtel site and to answer all health authorities questions.

**Essential Duties & Responsibilities**
- Preparation, coordination and update of production documentation for CMC regulatory submissions.
- Coordination between production and regulatory affairs.
- Response to question from authorities
- Authoring role in electronic submission management system.
- Write, review and approve Validation documents according to Takeda and Regulatory standards
- Participate in validation activities from planning, execution to validation reports
- Participate in internal or external audits, as required. Follow-up on audit observations topics and ensure closure on time

**What you bring to Takeda**:
**Required Skills**:

- Engineering or university degree (minimum MSc)
- Minimum 2-5 years of experience in CMC regulatory submissions and/or process validation for biopharmaceutical manufacturing
- Experience of applicable regulations and laws for biological products such as FDA CFR, cGMP, EU GMP, MD, EU directives and guidelines.
- Strong knowledge of manufacturing bioprocesses
- Strong verbal and written communication with ability to effectively communicate at multiple levels in the organization
- excellent communication and organization skills
- a self-confident positive attitude and a high degree of flexibility to cope with the dynamic conditions of submission projects and conditions.
- Fluent in English and French are a must

**What Takeda can offer you**:

- Attractive salaries
- Full accident cover
- Participation in health insurance premiums
- Advantageous retirement plans
- Subsidized meal
- Financial participation in the sports practices of its employees
- Transportation: support in local public transport, free parking, carpooling program
- Takeda Neuchâtel offers to its employees an attractive framework and working conditions. The well-being, safety, development and career development of its employees are at the heart of our vision and of our Human Resources, Health, Environment and Safety policies.
- Takeda Neuchâtel is an employer committed to its employees and future generations.

**More about us**:

- At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work._
- Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world._

**Empowering our people to shine**:

- 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 religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law._

**Locations**:
CHE - Neuchatel

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

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