Sr. Writer

3 settimane fa


Roma, Italia Thermo Fisher Scientific A tempo pieno

**Sr. Writer, Medical Information (US) - Evidera**
- **We are looking to fill this role remotely, in any of these locations: UK, Spain, France, Italy, Sweden**

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

**Location/Division Specific Information**

This position fits under Evidera. Evidera is now part of Thermo Fisher Scientific and is referred to as the Clinical Research Group (CRG). Over the coming year, we will be aligning our branding and messaging to be a part of Thermo Fisher Scientific. While integration activities occur, you may see reference/mention to Thermo Fisher Scientific, CRG, PPD and Evidera.

**How does Evidera fit into CRG**? The Clinical Research Group (CRG) provides clinical development, analytical and patient and advisory services that supports the clinical trial life cycle. As part of CRG, Evidera performs as a solutions-focused strategic partner that seeks to provide scientific expertise and operational capabilities to help biopharma and biotech customers generate the evidence needed to optimize the commercial potential of their products.

Effective communication of evidence and information is essential to conveying the value of products. With approximately 20 years of experience, our highly trained staff provide medical writing services for the peri
- and post-approval phases of the product lifecycle, helping to create a consistency in quality and voice. Our writers prepare documents that are clear, concise, compelling, and scientifically accurate, while also ensuring they are fully aligned with regulations, industry standard processes, and your corporate guidance.

**Discover Impactful Work**
- Independently researches, writes, and edits standard medical information writing materials (**global or regional standard response documents, custom responses, and FAQs**) across various therapeutic areas; Independently writes more complex medical writing materials. Provides senior review of documents and training/mentoring for other writers.
- Handles all aspects of planning, organizing, and completing projects without supervision, including: developing project timelines, standards, budgets, forecasts and contract modifications. Identifies and raises out-of-scope project activities in a timely manner and proposes solutions. May lead several long-term projects concurrently.
- Interacts with internal and external personnel on significant matters often requiring coordination between functional areas.
- Normally receives little instruction on day-to-day work, general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Represents the department as a prime contact on projects including Project Launch Meetings, Review meetings, client audits, bid defenses, and capabilities presentations. Establishes and develops client relationships. Assists with business development and development of budgets and proposals.

**Keys to Success**:
**Education and Experience**:

- Bachelor's degree in a scientific field or equivalent and relevant formal academic/vocational qualification.
- Proven experience as a Medical Information Writer that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’).
- Experience working in the pharmaceutical/CRO industry preferred.
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
- Ability to accurately work with, manipulate and format numbers, numerical information, and data of various types to provide evidence, information and insights.
- Able to analyze complex issues and evidence, identify cause-effect relationships and generate effective solutions.
- Able to create, communicate and handle effective project plans that support the delivery of overall project objective(s); to identify, lead and guide project team members; to monitor and report on progress in an organized fashion; and to deliver the required results.
- Demonstrates sound professional judgment in analyzing, responding to, and resolving enquiries, issues and customer concerns.
- Able to facilitate the resolution of conflict among team members and clients, through listening and understanding the cause(s), gaining agreement on an appropr


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