Associate Submission Medical Writer

Bayer CropScience Limited; Barcelona; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical industry is seeking an Associate Submission Medical Writer to support clinical submission documents. This role involves authoring clinical documents, ensuring compliance, and collaborating with various stakeholders. Ideal candidates will have significant experience in regulatory writing and a strong understanding of the drug development process.

Formación

• Minimum 8 years experience in the pharmaceutical industry.
• 5 years experience in regulatory medical writing.
• In-depth understanding of regulatory guidance and drug development.

Responsabilidades

• Authors clinical submission documents ensuring compliance and quality.
• Drives design of study-level clinical documents.
• Mentors junior medical writers.

Conocimientos

Communication

Regulatory Medical Writing

Clinical Document Development

Educación

Bachelor's degree

Master's degree

PhD

Herramientas

Electronic Authoring

Document Management

Descripción del empleo

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Associate Submission Medical Writer

Position purpose :

The Associate Submission Medical Writer supports the Submission Medical Writer and MW Strategist in designing and developing clinical submission documents. He / she independently authors individual clinical submission documents and ensures compliance, quality, alignment and consistency of all assigned clinical submission documents within a drug project, as well as alignment with the overall submission design and content strategy.

Major tasks and responsibilities :

• Independently authors study-level clinical documents and individual clinical submission documents and implements the submission authoring strategy under the leadership of MW Strategist or Submission Medical Writer.
• Drives the design of all assigned study-level and project-level clinical documents in support of the Global Clinical Development Plan under the leadership of MW Strategist or Submission Medical Writer.
• Validates the individual study protocol design and key messages in clinical study reports.
• Contributes to the project-level data presentation strategy and messaging standards under the leadership of MW Strategist or Submission Medical Writer.
• Mentors Senior Scientific Medical Writers and Scientific Medical Writers (internal and insourced) in developing expertise in writing submission documents.

Work interactions :

Internal Business partners :

• Works directly with the MW Strategist and Submission Medical Writer to develop and implement the global resource plan for the assigned submission document within the project.
• Works directly with the MW Strategist, Submission Medical Writer, Clinical Leader, Global Regulatory Strategist, Statistician, and other clinical and submission team members in developing the content strategy for global clinical submission documents within a project.

External business partners :

Medical writers, statisticians, and medical experts in contract research organizations.

Qualifications :

• This position requires a Bachelor’s degree and a minimum of 8 years experience in the pharmaceutical industry or a Master’s degree and a minimum of 6 years experience in the pharmaceutical industry, or a PhD and a minimum of 5 years experience in the pharmaceutical industry. In all cases, the candidate should have at least 5 years experience in regulatory medical writing, 3 of which should be in writing the submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.).
• PhD in natural sciences or equivalent degrees are highly preferred.
• The incumbent must have experience in developing clinical documents in support of regulatory submissions globally (i.e., multiple regions).
• The incumbent must have an in-depth understanding of all regulatory guidance, standards, and requirements pertaining to regulatory medical writing worldwide (e.g., ICH, FDA, EMEA).
• The incumbent must have a thorough understanding of the overall drug development process. Specific knowledge of the clinical study report development process, regulatory and drug safety requirements, and clinical data management and statistical processes / functions is required.
• Experience in supporting diverse therapeutic areas is preferred.
• The incumbent must also have an excellent working knowledge of current electronic authoring, document management, and electronic regulatory submissions.
• The incumbent must demonstrate strong communication skills, both written and verbal, required to articulate concepts and ideas. The incumbent must be diplomatic, persuasive, and able to establish rapport with all key functional leaders and experts in the Pharma Research & Development organization.

Division : Enabling Functions

Reference Code : 839339

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