R&a - Associate Principal Regulatory Writer (Aprw)

7 months ago

Melbourne, Australia Certara Full time

Overview:
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.

Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory approval process for our clients. The Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of clinical documents across different therapeutic areas. The APRW 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**:

- Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
- Lead a project team, and actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents)
- 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 collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result
- 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 project-related meetings and teleconferences
- Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements

Qualifications:

- Bachelor’s degree; MS or PhD preferred
- 8+ years of regulatory writing experience or equivalent experience with clinical sections of the CTD such as:

- 5 Clinical Overview
- 7 Clinical Summaries
- Clinical Study Reports
- Clinical Study Protocols
- Briefing Documents
- 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)
- Vaccine & Immunogenicity Regulatory Writing Experience is highly 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 own submission-level sections (e.g., clinical section [Module 2.7]), taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects
- Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
- 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
- Ability to resolve problems that arise, particularly in sensitive or high-pressure situations
- Possesses broad experience and technical expertise across more than one therapy area and integrates this knowledge to deliver business successes and actively transfer this knowledge to strength the skill base across the organization

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

  • Principal Medical Writer Ii

    4 weeks ago

    Melbourne, Australia CSL Full time

    The Principal Medical Writer is a key member of cross-functional clinical project teams. The incumbent will be responsible for planning, preparing, managing and coordinating medical writing projects for Clinical Development within R&D. They will mitigate risk associated with medical writing and disclosure processes by participating in the development and...

  • R&d Document Associate

    7 months ago

    Melbourne, Australia Bell People Consultants Full time

    Leading Pharmaceutical Global Manufacturing Organisation - Virology Background highly desirable - Melbourne Metropolitan Area - Long Term contract **About the company**: Operating as a leading global pharmaceutical manufacturing organisation with global sites worldwide, our client is well known for its growth and innovation and is an Australian iconic brand...

  • Principal Associate Regulatory Affairs Cmc

    3 months ago

    Melbourne, Australia CSL Full time

    We're looking for a Principal Associate, Regulatory Affairs CMC to join our team. In this strategic position, you will provide specialist strategic advice and support to Project/Product teams, Quality and Operations. Reporting to the local Head of GRA CMC your main responsibilities include: - Develop and implement the global CMC regulatory strategy for...

  • Business Consultant

    7 months ago

    Melbourne, Australia AMP Full time

    Business Consultant - Be part of a high performing team - Location: Melbourne - Initial 9 months contract - Hybrid role **The opportunity** Business Consultant, to play a crucial role in analysing and improving business processes within AMPs wealth product domain. This is contingent contract role working at AMP. **About the role**: - Leading the...

  • Assistant Product Manager

    4 months ago

    Melbourne, Australia AMP Full time

    Assistant Product Manager If you live in Australia or New Zealand, you've likely heard of AMP. But at a time when society is changing, we are too. We're now a nimbler business with new leadership and thinking. For us, these are exciting times. There's a real potential for big thinkers to help us redefine what financial services could be. And turn our...

  • Program Manager

    1 month ago

    Melbourne, Australia AMP Full time

    Program Manager - Be part of a high performing supportive team - Flexible work arrangements - work in a way that suits you best - Initial 12 Month contract - Location: Melbourne **Description of division and business unit** Platforms is one of two growth businesses for AMP, and as such, is supported by a substantial investment in projects. It exists in a...

  • General Counsel

    2 weeks ago

    Melbourne, Australia Culture Amp Full time

    **Join us on our mission to make a better world of work.** Culture Amp is the world’s leading employee experience platform, revolutionizing how 25 million employees across more than 6,500 companies create a better world of work. Culture Amp empowers companies of all sizes and industries to transform employee engagement, drive performance management, and...

  • Advice Operations Consultant

    6 months ago

    Melbourne, Australia AMP Full time

    Advice Operations Consultant If you live in Australia or New Zealand, you've likely heard of AMP. But at a time when society is changing, we are too. We're now a nimbler business with new leadership and thinking. For us, these are exciting times. There's a real potential for big thinkers to help us redefine what financial services could be. And turn our...

  • Advice Operations Consultant

    6 months ago

    Melbourne, Australia AMP Full time

    Advice Operations Consultant If you live in Australia or New Zealand, you've likely heard of AMP. But at a time when society is changing, we are too. We're now a nimbler business with new leadership and thinking. For us, these are exciting times. There's a real potential for big thinkers to help us redefine what financial services could be. And turn our...

  • Business Consultant

    7 months ago

    Melbourne, Australia AMP Limited Full time

    Be part of a high performing team - Location: Melbourne - Initial 9 months contract - Hybrid role **The opportunity** Business Consultant, to play a crucial role in analysing and improving business processes within AMPs wealth product domain. This is contingent contract role working at AMP. **About the role**: - Leading the end-to-end BA delivery with...

  • Assistant Product Manager

    4 months ago

    Melbourne, Australia AMP Limited Full time

    If you live in Australia or New Zealand, you’ve likely heard of AMP. But at a time when society is changing, we are too. We’re now a nimbler business with new leadership and thinking. For us, these are exciting times. There’s a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy into something even...

  • Advice Operations Consultant

    1 day ago

    Melbourne, Australia AMP Limited Full time

    **The opportunity** The main purpose of this role is to deliver excellent administration and support services to AMP’s Aligned and Non-Aligned advice network by completing a regulated set of business processes and maintaining effective quality, timing & risk controls within the team. A focus on problem solving and continuous improvement identified through...

  • Program Manager

    1 month ago

    Melbourne, Australia AMP Limited Full time

    Be part of a high performing supportive team - Flexible work arrangements - work in a way that suits you best - Initial 12 Month contract - Location: Melbourne **Description of division and business unit** Platforms is one of two growth businesses for AMP, and as such, is supported by a substantial investment in projects. It exists in a very competitive...

  • Technical Writer

    3 weeks ago

    Melbourne, Australia Mantech Full time

    **Role**: Technical Writer **Location**: Melbourne, VIC **Salary**: TBD **About the company**: Our client is a global leader in providing innovative solutions across specialized industries. Their focus is on delivering advanced products and technologies that address complex challenges. Known for their commitment to quality and excellence, they pride...

  • Equity & Inclusion Specialist

    4 days ago

    Melbourne, Australia Culture Amp Full time

    **Join us on our mission to make a better world of work.** Culture Amp revolutionizes how over 25 million employees across 6,000 companies create a better world of work. As the global platform leader for employee experience, Culture Amp empowers companies of all sizes and industries to transform employee engagement, develop high performing teams, and retain...

  • Advice Operations Consultant

    7 months ago

    Melbourne, Australia AMP Limited Full time

    If you live in Australia or New Zealand, you’ve likely heard of AMP. But at a time when society is changing, we are too. We’re now a nimbler business with new leadership and thinking. For us, these are exciting times. There’s a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy into something even...

  • Advice Operations Consultant

    6 months ago

    Melbourne, Australia AMP Limited Full time

    If you live in Australia or New Zealand, you’ve likely heard of AMP. But at a time when society is changing, we are too. We’re now a nimbler business with new leadership and thinking. For us, these are exciting times. There’s a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy into something even...

  • Regulatory Affairs Associate

    6 months ago

    Melbourne, Australia u&u Recruitment Partners Full time

    About the company Our client is a ASX global pharmaceutical company recognised as the pioneers of treatments for patients with a variety of life-threatening disorders. About the role The Regulatory Affairs Associate will support the Regulatory Team in: Obtain regulatory approvals globally for designated product portfolio; Manage national regulatory...

  • Regulatory Affairs Associate

    7 months ago

    Melbourne, Australia u&u Recruitment Partners Full time

    About the company Our client is a ASX global pharmaceutical company recognised as the pioneers of treatments for patients with a variety of life-threatening disorders. About the role The Regulatory Affairs Associate will support the Regulatory Team in: Obtain regulatory approvals globally for designated product portfolio; Manage national regulatory...

  • Associate Principal Viola

    9 months ago

    Melbourne, Australia Melbourne Symphony Orchestra Full time

    **Expressions of Interest** Exceptional musicians are invited to submit an expression of interest for the permanent position of Associate Principal Viola. **Application Details** Auditions Coordinator Melbourne Symphony Orchestra