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PPD Sr. Writer, Medical Information (US) - Evidera in Waltham, Massachusetts

Sr. Writer, Medical Information (US) - Evidera

*We are looking to fill this role in one of our locations in US 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:_

As aSr. Medical Information Writer, you will providehigh-qualitymedicaland scientificwritingfrom planningand coordination of literature search through delivery offinal drafts to internalandexternal clients.You will providetechnicalconsultationandadviceon strategy, regulationsand industrybest practices.

_Key Skills and Attributes_

  • Ability toeffectivelymanagemedicalwriting projects to deliver quality productsinagreedtimelines bydemonstratingsubjectmatterand therapeuticareaexpertise.
  • Collaboratingwith internalandexternalclients,supportingandenabling effectiveandefficient communicationthat results inoperationalexcellence.

_Job Responsibilities_

  • Independently researches, writes, and edits standard medical information writing deliverables across various therapeutic areas. Independently writes more complexmedical information writing deliverables. Examples may includeglobal or regional standard response documents, custom responses, and FAQs. Provides senior review of documents and training/mentoring for other writers.
  • Manages all aspects of planning, organizing, and executing projects without supervision, including: developing project timelines, standards, budgets, forecasts and contract modifications. Liaises with other functional units as necessary. Identifies and escalates out-of-scope project activities in a timely manner and proposes solutions.
  • May manage several long-term projects concurrently.
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.
  • Normally receives little instruction on day-to-daywork, general instructions onnewassignments.Demonstrates goodjudgmentin selectingmethodsandtechniquesfor obtainingsolutions.
  • Represents the department as a prime contact on projects including Project Launch Meetings, Review meetings, client audits, bid defenses, and capabilities presentations.Establishes and develops client relationships; independently initiates and leads interactions with clients. Assists with business development and development of budgets and proposals.

_Minimum Education Level/Years of Experience_

  • Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred.
  • Previous experience*as a Medical Information Writer *that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years’) or equivalent combination of education, training, & experience.
  • Experience working in the pharmaceutical/CRO industry preferred.
  • Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.

_Specific skills or knowledge required for position _

  • Aptitude to accurately work with, manipulate and format numbers, numerical information, and data of various types to provide evidence, information and insights.
  • Demonstrated ability to communicate and document information effectively in written English, including the ability to produce reports, documents, emails and other written pieces which are well-organized, free from errors and are appropriately adjusted to the characteristics and needs of the audience.
  • Able to analyze complex issues and evidence, identify cause-effect relationships and generate effective solutions.
  • Able to create, communicate and manage effective project plans that support the delivery of overall project objective(s); to identify, manage and guide project team members; to monitor and report on progress in an organized fashion; and to deliver the required results.
  • Demonstrates sound professional judgment in analyzing, responding to, and resolving enquiries, issues and escalations.
  • Able to facilitate the resolution of conflict among team members and clients, through listening and understanding the cause(s), gaining agreement on an appropriate course of action, and following up to ensure a successful outcome.

_Computer programming or software skills required for position_

  • Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).

_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:

Evidera offers a competitive salary and benefits package, with clear opportunities for growth and career progression. We promote a flexible working environment and provide access to Employee Well-being programs and services. You will have the opportunity to work on multiple projects with some of the industry’s leading researchers around the globe. We are committed to providing training and professional development, with ample opportunity for advancement for all our staff.

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:

  • 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.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

If you resonate with our 4i values above, and ultimately 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!

#LI-REMOTE

Job: *Medical Writing

Organization: *US BU

Title: Sr. Writer, Medical Information (US) - Evidera

Location: MD-Bethesda-Bethesda MD

Requisition ID: 211850

Other Locations: United States, US-MA-Waltham-Evidera Waltham MA

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

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