Medical Writer Consultant

Frazer, PA

Posted: 03/28/2019 Job Number: JN -032019-10579
Consultant Medical Writing:

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: Consultant Medical Writing
  • Location: Frazer, PA
  • Industry: Pharmaceutical
  • Hours: Monday-Friday; 8:00 am 5:00 pm
  • Salary: $60.00 hour-$65.00 hour paid weekly with benefits options
  • Employment Type: Contract 1 year with possible extension or conversion
Environment: This client is a worldwide leading generic pharmaceutical company and one of the top 15 companies in the industry. With over 45,000 employees in 60 countries worldwide, they are proud to say that our employees are the reason for our success . They believe in empowering employees, presenting them with new challenges and letting them grow and develop professionally. Isn t this the type of company you want to work for?

Job Scope:
  • Performs accurate and precise editing or proof- reading to include spelling, grammar, punctuation and verification of data.
  • Assesses validity of clinical statements described in documents provided to governmental Health Authorities and identify discrepancies.
  • Provides independent clinical review of clinical summary documents, study reports, Investigator s Brochures, Clinical Protocols, Briefing Books, etc, prior to submission to Health Authorities.
  • Ensures quality and timeliness of reviewing and editing of clinical documents and submissions.
  • Verifies content to ensure accuracy (100% review) of all factual statements within document text compared to post-text sources cited (when appropriate).
  • Verifies numeric accuracy (100% review) of all data cited throughout text compared to in-text or post-text tables.
  • Verifies citation notation on all internal and external citations noted within summary document.
  • Ensure compliance of document format per the template and Style Guide.
  • Develops and provide factual evidence to support all discrepant findings for review and approval by Submission Team or document authors.
  • Mentors and/or trains new or junior QC specialists to achieve department set goals for excellence in quality review.
  • Provides cross-divisional support through quality review of T&D documents and other nontraditional clinical documents.
  • Leads resolution of discrepant findings with Submission Team or author, including documenting actions, verifying implementation of findings and archiving results (if appropriate).
  • Works cross functionally to continuously improve processes

Skills Needed:
  • PhD or Master s Degree in English/Life Sciences, Bachelor s Degree with at least 5 years of experience
  • 5 years in the pharmaceutical or medical industry with at least 2 years in Medical Writing
  • 5 years in the pharmaceutical or medical industry
  • Specialized or Technical Knowledge Licenses, Certifications needed: Proficient in Microsoft Office, Documentum, Hyperlinking, and Bookmarking
  • ability to fluently read, write, understand and communicate in English
  • Experience in clinical research with proven proficiency in global clinical development
  • Ability to understand and interpret complex clinical and/or scientific and statistical data and effectively communicate inaccuracies in technical documents to authors.
  • Demonstrate strong medical and/or scientific communications (written)
  • Proven ability to work independently to deliver clinical technical document discrepant findings within defined timelines.
  • Previous experience in clinical development of clinical technical document deliverables with knowledge in world-wide regulatory requirements for drug and device registration
  • Ability to conduct thorough and accurate research, have logical organizational skills, clear readable writing, and adherence to required templates.
  • Solid computer technical skills (Word/Excel/PDF development), ability to acquire skills in accordance with company and external writing standards, and learn new systems quickly.
  • Strong knowledge of global regulatory requirements
  • An understanding of the clinical drug development process, including clinical trial design, operations, and results analysis
  • Knowledge of global regulations and AMA style
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