WRITER, MEDICAL INFORMATION - EVIDERA

Medical Information Writer - Evidera
*We are looking to fill this role in one of our locations in US or Europe as an office-based or home-based employee

Effective communication of evidence and information is essential to conveying the value of products. With approximately 20 years of experience, our highly trained staff provide medical writing services for the peri- and post-approval phases of the product lifecycle, helping to create a consistency in quality and voice. 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 Summary:

In this role, you will provide high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. You will provide technical consultation and advice on strategy, regulations and industry best practices. As a Medical Information Writer you will demonstrate subject matter and therapeutic area expertise. You’d have to effectively manage medical writing projects to deliver quality products in agreed timelines. You will collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Key Skills and Attributes

• Independently researches, writes, and edits standard medical information writing deliverables across various therapeutic areas; may also independently write, or assist with more complex medical writing deliverables. Examples may include global or regional standard response documents, custom responses, and FAQs.

Job Responsibilities

• Participates in developing project timelines, standards, budgets, forecasts, and contract modifications.
• Assists in the management of project budget and forecast.
• Contributes to developing contract modifications with oversight.
• May represent Medical Writing in bid defenses and capabilities presentations.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Develops professional expertise and applies company policies and procedures to resolve a variety of issues.
• Normally receives general instructions on routine work, and more detailed instructions on new projects or assignments. Exercises judgment within defined procedures and practices to determine appropriate action.
• Contacts are primarily internal to the company, but may have frequent external customer/ vendor contacts on routine matters. Builds productive internal/external working relationships.

Minimum Education Level/Years of Experience

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational
• qualification.
• Previous experience as a Medical Information Writer that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years’) or equivalent combination of education, training, & experience.
• Experience working in the pharmaceutical/CRO industry preferred.
• Solid medical writing skills, including grammatical, editorial, and proofreading skills.
• Ability to interpret and present complex data accurately and concisely.
• Good knowledge of regulatory documentation and drug development process.
• Good computer skills and skilled with client templates.
• Good knowledge of document management systems and other relevant applications (e.g. Word, Excel,Outlook).

Specific skills or knowledge required for position

• Effective administrative, organizational and planning skills; attention to detail and quality.
• Ability to work on own initiative and effectively within a team.
• Effective oral and written communication skills.
• Great judgment and decision-making skills.

ADA Requirements

• Normal and routine office duties.
• Domestic and international travel may be required.

About Evidera:

Evidera is a business within in 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.

Perks:

We offer a competitive salary and benefits package, with clear opportunities for growth and career progression. You will have the opportunity to work on multiple projects with some of the industry’s leading researchers. Our offices boast a fun and collaborative working environment, frequent social events and a robust support system. We are committed to providing training and professional development, with ample opportunity to advance, for all our staff.

Evidera’s Core Competencies:

• Customer Focus
• Initiative
• Teamwork
• Problem Solving/Judgment
• Accountability

If you resonate with our core competencies and want to contribute to research and consulting services driven by world-class science and thought leadership, then please submit your application – we’d love to hear from you.

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 and 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. (Recruiter will provide more details.)

  #LI-REMOTE

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.