Senior Medical Writer

Job Description

The Study Documentation Team, a part of Medical Writing and Healthcare Communications at Evidera, provide medical writing services for all phases of the product lifecycle, with a focus on peri- and post approval, as part of a dynamic and highly collaborative team. Our writers prepare documents that are clear, concise, compelling, and scientifically accurate, while also ensuring they are fully compliant with regulations, industry best practices, and your corporate guidance.

Position Overview:

We are looking for an experienced regulatory writer to join the Study Documentation Team as a Senior Medical Writer. The Senior Medical Writer will be responsible for managing and producing high-quality regulatory documents. The successful candidate will have extensive experience in writing clinical study reports (CSRs), study protocols, informed consent forms (ICFs), experience in other regulatory documents advantageous, e.g., lay summaries, Investigator Brochures (IBs), Investigational New Drug (IND) Application , Marketing Authorisation Applications (MAAs)  , as well as excellent written English and analytical skills. We are looking for a team player who is proactive, enjoys challenges, is able to work on multiple projects concurrently, and is comfortable working in a highly collaborative CRO environment.

Essential Duties and Responsibilities (other duties may be assigned):

• Write, edit, and manage clinical study reports (CSRs), study protocols, informed consent forms (ICFs), and other regulatory documents on time, within budget, and with little instruction
• Appropriately resolve or escalate project management issues, such as out-of-scope activities
• Ensure compliance with regulatory requirements and quality processes and requirements
• Represent the team as a prime contact on projects
• Lead or provide input on initiatives for process improvement

Education, Professional Skills, & Experience:

• Extensive relevant experience as a writer of regulatory documents (comparable to 5+ years); experience working in a CRO environment preferred
• Excellent regulatory writing, project management, and computer skills
• Bachelor’s degree or higher in a scientific discipline; advanced degree preferred
• In-depth knowledge of relevant specialty areas of medicineAdditional qualifications (AMWA, EMWA) advantageous

Personal Skills & Competencies:

• Excellent written English
• Excellent analytical and problem-solving skills
• Sound professional judgement in dealing with inquiries, issues, and escalations; able to independently make decisions and solve problems
• Comfortable working on multiple projects concurrently
• Able to complete work within fixed budgets and timelines
• Able to facilitate conflict resolution among team members and clients
• Proactive communicator

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive and understand information & ideas with diverse groups of people in a comprehensible and reasonable manner
• Able to work upright and stationary for typical working hours
• Ability to use and learn standard office equipment and technology with proficiency
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
• May require travel

Who we are?

Evidera is a business within Pharmaceutical Product Development, LLC (PPD) a leading global contract research organization (CRO), and a is a preeminent provider of evidence-based solutions. We provide integrated scientific expertise and global operational capabilities to help clients generate the evidence needed to optimize the market access and commercial potential of products.

What we offer?

We know that if you are provided with the right support and resources needed you will thrive! Therefore, Evidera offers a great mix of compensation and benefits options to show you how valuable you are to the organization.

Some of our perks include:

• Highly competitive salary and bonus structure
• Generous benefits package, including healthcare, dental, vision and paid time off to spent with your friends and family
• Flexible working environment by offering fully remotework for most of our positions, to support work-life balance
• Clear opportunities for growth and career progression. We offer multiple Learning & Development programs, coaching and mentoring trainings, career planning and discussions to help you grow as a professional.
• Access to Employee well-being programs and services. We value your emotional health and offer a variety of programs to support your mental healthcare.
• Collaborative working environment with focus on diversity and inclusion. At Evidera, we respect one another and recognize that our diversity makes our business stronger. We strive to be an inclusive organization where colleagues can be their authentic selves and grow their careers.
• Global exposure: Opportunity to work on multiple projects with some of the industry’s leading researchers around the globe
• Smooth onboarding process with your own dedicated onboarding specialist and a working buddy to help you navigate through your first few weeks thus ensuring great start to your new role

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

Our 4i Values are critical components in accomplishing our mission. These values guide us and, ultimately, define us.

If you resonate with them and wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!*