Massachusetts Creative Jobs

MassHire Job Quest Logo

Job Information

PPD Sr Document Review Specialist - Evidera in Waltham, Massachusetts

SR DOCUMENT REVIEW SPECIALIST
*We are looking to fill this role in US or Europe

/Evidera is a global research consulting group that partners with life sciences organizations worldwide to develop, capture and communicate the clinical and economic evidence required to substantiate the value of their products and optimize their products’ market access and commercial success. Our research and consulting services are driven by world-class science and thought leadership and leverage a unique combination of capabilities in health economics, outcomes research, market access, data analytics and epidemiology./

We are currently looking for an individual experienced in medical editing to join our growing Medical Writing and Healthcare Communications team as aSr. Document Review Specialist!

_Position Overview_

Effectively reviews documents created within or outside of the company to ensure quality of a standard that meets or exceeds client's expectations. Documents include study protocols, integrated clinical study reports, manuscripts, medical information deliverables, various scientific communication deliverables, and more. Ensures integrity of data against source documents. Instructs others outside of the document review group on the review process.

_Essential Duties and Responsibilities (other duties may be assigned):_

  • Reviews highly technical documents of all types created within or outside of the company to ensure a quality standard that meets or exceeds the client's expectations.
  • Ensures scientific logic and clarity of the document by verifying data against source documents and checking for consistency according to current regulatory standards and guidelines.
  • Edits for accuracy, consistency and grammatical correctness.
  • Revises scientific language for usage, flow, clarity and audience appropriateness.
  • Adjusts schedule to accommodate unexpected requests for priority review.
  • Proactively queries authors to ensure compatibility with unique preferences and scientifically sound judgment.
  • Maintains, communicates and applies knowledge of current guidelines, templates and industry standards.
  • Coordinates the work of team members and tracks the status of documents being reviewed.
  • Mentors junior team members. May represent the department at meetings with clients.
  • Contributes to the development and modification of the document review process.
  • Collaborates with medical writers and/or project managers to manage alliance account(s).
  • Delegates weekly assignments to the document review team and fields questions as appropriate.

_Education, Professional Skills & Experience:_

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
  • Previous scientific editing experience, including copyediting, fact-checking and/or formatting experience, that provides the knowledge, skills and abilities to perform the job (comparable to 5 years’).
  • BELS certification is highly preferred.

_Personal Skills & Competencies:_

Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document's message.

  • Thorough knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g. ICH) and requirements of the FDA and other international regulatory agencies.
  • Familiarity with interpreting data and excellent analytical ability.
  • Effective oral and written communication skills. Good organizational and planning skills.
  • Good interpersonal skills. Ability to work on own initiative.
  • Good computer literacy and expertise. Competent word processing skills.
  • Solid understanding of document management systems.
  • Suitable level of expertise within a broad range of medical writing projects.
  • Good knowledge of global and regional medical writing and regulatory affairs duties for clinical trials, marketing authorization and late-phase procedures.
  • Capable of providing general advice and training to others. Capable of working well under pressure and remaining motivated.
  • Capable of working both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment.

About Evidera:

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.

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

Job: *Medical Writing

Organization: *US BU

Title: Sr Document Review Specialist - Evidera

Location: MA-Waltham-Evidera Waltham MA

Requisition ID: 202056

Other Locations: GB-GB-Birmingham, United Kingdom, United States, GB-GB-London-London UK, US-Massachusetts, US-Maryland, GB-GB-Bellshill, GB-GB-Cambridge, US-MD-Bethesda-Bethesda MD, GB-GB-Glasgow

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

DirectEmployers