Specialist, Clinical Research

Location
Gaithersburg, MD, US
Posted
Feb 20, 2021
Ref
694107400
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

CLINICAL WRITING PROFESSIONAL

20 Month Term Position

Emergent BioSolutions is currently seeking a Clinical Writing Professional for our Winnipeg site. The successful candidate will have a degree in Life Sciences/Health Related Sciences, accompanied by 3+ years of relevant experience. The ideal candidate will have a passion for editing and pagination, with technical expertise in style guide application, medical writing templates and software and familiarity with clinical data, statical and data output. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

THE COMPANY

Emergent BioSolutions is dedicated to one simple mission-to protect and enhance life.

As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

THE OPPORTUNITY

This position manages the document compilation process, writes, and edits clinical document deliverables for the Clinical Development department. The position works in collaboration with other department subject matter experts to integrate content from multiple channels to produce high quality clinical documents including but not limited to clinical study protocols, clinical study reports, investigator's brochures and clinical regulatory submission documents. The position oversees the review process and quality control procedures of clinical documents and ensures documents are published within Emergent systems according to company templates and style guide requirements. This position ultimately serves as the expert in managing content, formatting, editing and delivery of clinical documents within required timelines.

DUTIES & RESPONSIBILITIES

  • Responsible for clinical development writing and document management of clinical submission documents including clinical study protocols, clinical study reports (CSRs), Investigator's brochures, and clinical submission documents (including CTD sections, meeting packages, annual reports).
  • Compile, write, and edit clinical development writing deliverables, and serves as a technical writer within and across departments with minimal supervision.
  • Coordinate and edit document content in collaboration with subject matter experts in medical science, clinical research, biostatistics and data management, clinical operations, and project teams including pre-clinical and regulatory affairs.
  • With general medical/scientific experience as well as with training in study disease area, develop initial document shells or drafts using appropriate and approved templates and writing styles and formats.
  • Work with SMEs, review and interpret clinical data for accurate description and summary in clinical documents.
  • Organize review and approval process of clinical submissions documents, coordinate meetings, which includes authoring documents in a team environment, generating consensus/decisions among reviewers, and facilitating discussions in an efficient manner to meet project timelines.
  • Perform effective editing on assigned clinical development writing documents to refine them before releasing them for internal and external review.
  • Perform clinical literature searches and summaries literature data with SMEs.
  • Work with medical communications to prepare abstracts for scientific meetings and scientific publications according to company policies for public disclosure and coordinate internal review for public disclosure.
  • Develop/revise procedures (SOPs and Working practices) and tools related to authoring and reviewing of clinical documents.
  • Apply knowledge in the drug development process and regulatory requirements for clinical studies and submission, including provision of expertise in clinical deliverables for format and content for compliance with Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) and relevant guidelines and regulations.
  • May act as clinical trial registry administrator, to track and ensure QC and compliance with regulations.


The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

EDUCATION, EXPERIENCE & SKILLS:

  • Degree in Life Sciences/Health Related Sciences or equivalent.
  • Clinical research and/or medical/technical writing experience in biopharmaceutical industry, accompanied by over 3 years of relevant experience. A professional medical writing certification (e.g., AMWA, EMWA, RAPS) would be an asset.
  • Excellent written and verbal communication skills. Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
  • A passion for editing and pagination, with technical expertise in style guide application, medical writing templates and software.
  • Ability to exercise independent judgement in developing methods, techniques, and evaluation criteria for obtaining results.
  • Familiarity with clinical data, statistical and data output.
  • Prior CSR and Summary Document generation experience and knowledge of submissions in Common Technical Document (CTD) format is an asset.
  • Experience-based understanding of applicable regulations and guidelines (eg, Code of Federal Regulations, European Directive, and International Conference on Harmonisation).
  • Strong computer skills; proficiency in MS Word, Excel, and Power Point.
  • Proven problem solving and decision-making skills.
  • Capable of interacting effectively at all levels with external contacts including collaborators, partners and contract organizations, and at every level within the Company.
  • Well-developed planning and tracking skills with a demonstrable understanding of the importance of effective planning and tracking in project and resource management.


ADDITIONAL REQUIREMENTS:

  • Citizenship/Permanent Resident or Valid Work Permit.
  • Successful Completion of a Criminal Record Check.


Interested? Please visit www.emergentbiosolutions.com under the career section to apply today!

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

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