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Sr. Regulatory Medical Writer

vor 1 Woche

Berlin, Deutschland Certara Vollzeit

**At Certara, we accelerate medicines to patients by partnering with life science innovators.**

**Certara**:
Certara (CERT) is the largest and most comprehensive provider of strategic drug development, modeling & simulation and regulatory science services. We partner with biopharmaceutical businesses to optimize drug development decisions and accelerate the drug development process.

At Certara, you will play an important role helping our clients develop new therapies and target unmet medical needs, expand the benefits of existing therapies to other populations, communicate scientific information in the language of regulatory success, balance risk profiles, differentiate drugs from a competitive perspective, and unlock millions in R&D savings. Ultimately, you’ll be helping more critical drug products get to more patients,

Certara has global team ~1000 employees with more than 300 PhD, PharmD, and MD scientists and regulatory writers, working on key drug development projects for biopharmaceutical companies.

**Our Employees Enjoy**:

- ** Opportunity for career advancement that align to your professional aspirations.**:

- ** Collaborative work environment where you will continuously learn and work towards a common goal.**:

- ** Competitive benefits and compensation packages that reward your strong performance.**:

- ** Genuinely impactful work that will make a difference to the lives of people all over the world**

**Job Overview**:
Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory approval process for our clients. The Senior Regulatory Writer (SRW) is a major contributor to document authorship for a variety of documents across different service lines. The SRW will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery team.

**Responsibilities**:
Lead or participate in a project team which may be led by a Principal Regulatory Writer or Associate Principal Regulatory Writer

Author documents per client specifications, templates, style guides, and other guidance documents

Author documents per regulatory authority guidelines and requirements

Act as client advisor, working with all parties to lead development of strategies for organizing and preparing regulatory documents

Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work

Manage budget for a low complexity project, including all contributors (writers, editors)

Usher documents through the review process, conduct comment resolutions meetings (CRMs), and successfully lead a project team to consensus

Maintain collaborative, proactive, and effective communication with both client and internal teams

Lead or participate in project-related meetings and teleconferences

Provide coaching to junior staff for study level documents

**E**ducation, Experience, Training, and Knowledge**:
Bachelor’s degree

3+ years of regulatory writing experience or equivalent experience with clinical
- related documentation

Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when

seeking health authority approval/acceptance

Experience in the development of submission-level documents (does not require functioning as a document lead)

Experience in the development of pharmacovigilance documents

Fluent in Dutch (speaking and writing) is preferred

**Skills & Abilities**:
Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques

Strong understanding of the document creation process and of the drug development lifecycle

Able to synthesize data across multiple data sources and documents to create summary reports

Ability to conduct/lead a CRM and successfully lead a project team to consensus

Ability to use logical arguments to persuade others when presenting ideas and suggestions, but also respond positively to opposing views voiced by others

Develops professional relationships with clients as a way to further the business relationship and maintain current industry knowledge

Ability to identify and institutionalize work practices that are most effective in order to ensure consistency in performance

Location: Netherlands - Office-based, hybrid or remote-based

**About Certara**

Certara is a growing company that provides a novel and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post