Sr. Regulatory Medical Writer

il y a 3 semaines

Paris e, France Certara Temps plein

**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

  • Principal Regulatory Writer

    il y a 3 semaines

    Paris 8e, France Certara Temps plein

    **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...

  • Medical Writer

    il y a 3 semaines

    Paris, France Cmed Temps plein

    Cmed is seeking a Medical Writer with regulatory medical writing experience for this client dedicated opportunity. Experience with at least 2 of the documents: abbreviated protocol, protocol, and subsequent amendments, amended protocols, clinical study reports (all phases), lay summary of results, narratives, Clinical modules of CTDs, Q&A, P70, investigators...

  • Medical Writer

    il y a 2 semaines

    Paris 4e, France Cmed Temps plein

    Cmed is seeking an EU based Medical Writer with regulatory medical writing experience for this client dedicated opportunity. Experience with at least 2 of the documents: abbreviated protocol, protocol, and subsequent amendments, amended protocols, clinical study reports (all phases), lay summary of results, narratives, Clinical modules of CTDs, Q&A, P70,...

  • Junior CMC Regulatory Technical Writer

    il y a 5 jours

    Paris, France Excelya Temps plein

    Role SummaryThe CMC Regulatory Department is seeking an experienced and detail-oriented Junior CMC Regulatory Technical Writer to join our team. The ideal candidate will play a crucial role in the preparation and submission of high-quality CMC regulatory documents including Module 2 and Module 3 that support our registration activities for small molecule,...

  • Junior CMC Regulatory Technical Writer

    il y a 5 jours

    Paris, France Excelya Temps plein

    Role Summary The CMC Regulatory Department is seeking an experienced and detail-oriented Junior CMC Regulatory Technical Writer to join our team. The ideal candidate will play a crucial role in the preparation and submission of high-quality CMC regulatory documents including Module 2 and Module 3 that support our registration activities for small molecule,...

  • Junior CMC Regulatory Technical Writer

    il y a 5 jours

    Paris, France Excelya Temps plein

    Role Summary The CMC Regulatory Department is seeking an experienced and detail-oriented Junior CMC Regulatory Technical Writer to join our team. The ideal candidate will play a crucial role in the preparation and submission of high-quality CMC regulatory documents including Module 2 and Module 3 that support our registration activities for small molecule,...

  • Junior CMC Regulatory Technical Writer

    il y a 3 jours

    Paris, France Excelya Temps plein

    Role Summary The CMC Regulatory Department is seeking an experienced and detail-oriented Junior CMC Regulatory Technical Writer to join our team. The ideal candidate will play a crucial role in the preparation and submission of high-quality CMC regulatory documents including Module 2 and Module 3 that support our registration activities for small...

  • Freelance Medical Writer

    Il y a 7 mois

    Paris, France Klick Health Temps plein

    **Please submit your resume in English** **Scientific Knowledge and Skills**: - Combines a thorough understanding of the therapeutic area with product strategy to ensure communication objectives are met on assigned projects. - Is able to identify and leverage relevant, focused resources to understand the underlying science and product strategy related to...

  • Freelance Medical Writer

    Il y a 4 mois

    Paris, France Klick Health Temps plein

    **Please submit your resume in English** **Scientific Knowledge and Skills**: - Combines a thorough understanding of the therapeutic area with product strategy to ensure communication objectives are met on assigned projects. - Is able to identify and leverage relevant, focused resources to understand the underlying science and product strategy related to...

  • Chargé D'affaires Réglementaires

    il y a 2 semaines

    Paris, France BIORIUS - Your cosmetic regulatory expert Temps plein

    **About BIORIUS** **About the Position** Historically focused on human health, BIORIUS is adapting to the new constraints and opportunities suggested by its market. The Medical Device business unit recruits a Regulatory Affairs / Quality Specialist. Since many developments are expected and capacity building is needed, this position requires a senior...

  • Medical Writter

    il y a 2 semaines

    Paris 14e, France SMART IMMUNE Temps plein

    **SMART IMMUNE RECRUTE UN(E) MEDICAL/SCIENTIFIC WRITTER H/F EN CDI** SMART IMMUNE est une société de biotechnologie au stade recherche clinique qui développe les thérapies cellulaires issues de progéniteurs de lymphocytes T à travers une plateforme innovante appelée ProTcell. Ces thérapies cellulaires, nouvelle génération, permettent en un temps...

  • Medical Writer

    Il y a 5 mois

    Paris, France Calypse Temps plein

    Prise de poste non définie BAC +3/+4 Paris Nombre de postes non défini CDI À négocier **Description du poste et des missions**: **Poste** Medical Writer **Mission** Le rédacteur médical sera un contributeur actif/auteur principal de la documentation réglementaire et scientifique, gérera la collecte globale de contenu auprès d'équipes...

  • Regulatory Affairs Specialist

    Il y a 7 mois

    Paris, France Nanobiotix Temps plein

    Nanobiotix is happy to welcome a CMC manager, regulatory affairs to provide valuable support to our mission to advance groundbreaking nanomedicine solutions. At the forefront of pioneering nanomedicine approaches that could redefine cancer treatment, our team at Nanobiotix is dedicated to creating innovative solutions to impact countless lives across the...

  • Sr. Project Manager

    il y a 3 semaines

    Paris 8e, France Certara Temps plein

    **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...

  • Senior Global Regulatory Affairs Specialist

    Il y a 7 mois

    Paris, France Novasyte Temps plein

    Job Overview Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. Independently provides regulatory support for more complex projects. Essential Functions - Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or...

  • Senior Regulatory Affairs Specialist

    Il y a 3 mois

    Paris, France Philips Temps plein

    **Job Title**: Senior Regulatory Affairs Specialist Job Posting Description **In this role, you have the opportunity to** Ensure that products comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions, and enablers for SaMD products supporting the Cardiologs business within Ambulatory...

  • Regulatory Affairs Specialist

    il y a 2 semaines

    Paris 4e, France VIQI Temps plein

    **Your responsibilities** - Maintaining the Technical Documentation for Medical Devices with support of other functions - Becoming familiar with regulations and standards applicable to specific areas of responsibility, which may include notified body exposure - Support product registrations including document management - Support the Medical Device team in...

  • Cmc Regulatory Manager

    Il y a 7 mois

    Paris, France Excelya Temps plein

    Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...

  • Senior/ Regulatory Affairs Manager

    Il y a 7 mois

    Paris, France Novasyte Temps plein

    Job Overview Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. Works independently under limited supervision. Essential Functions - Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project,...

  • Stagiaire Medical Writer

    il y a 3 semaines

    Paris 13e, France BioSerenity Temps plein

    **Société**: Fondée en 2014 au sein de l'Institut du Cerveau et de la Moelle Épinière (ICM) à l'hôpital de la Pitié-Salpêtrière (AP-HP, Paris), Membre du programme Next 40, BioSerenity est une société connue comme étant l'une des Deep Tech française les plus innovantes dans l'écosystème de la e-santé. Bioserenity a pour but d'améliorer la...