DOCS Medical Writer in St. Paul, Minnesota
Ref #: 27847
Employment type: Permanent - Full-Time
At DOCS, we care about our people and their passion, as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We have over 4500 employees globally working on novel therapies that deliver real impact to patients in need.
All our team members have the independence to get the job done and support from the experienced leadership team when you need it. If you want a career with a difference, DOCS is the place for you.
The CDD&T Medical Writer will prepare trial disclosure documents in compliance with trial transparency laws and requirements and client policies.
• Clinical trial registration and results posting on www.ClinicalTrials.gov; results posting on EudraCT.
• Coordinating quality assurance reviews of documents and maintain audit trails of changes.
• Prepares scientifically valid draft and final results summaries for posting to ww.ClinicalTrials.gov and EudraCT, inclusive of the scientific interpretation of data, and the writing of clinical, pharmacokinetic and pharmacodynamic results for studies of varying complexity and therapeutic designation.
• Complete work in a timely and accurate manner in accordance with Client Standard Operating Procedures and FDA/EMA regulatory requirements.
• Assures study registrations and results postings are in accordance with FDAAA (Food and Drug Administration Amendments Act of 2007) compliance, EMA guidelines, and the client SOPs.
• Performs review of results summary content and validity for studies as assigned and works with the TA Lead/Trial Transparency Specialist as needed to resolve any issues with the clinical project team before the results are finalized and ready for posting.
• Responds to Client comments on the results summaries; amends summaries as appropriate and incorporates review findings prior to finalizing for posting on www.ClinicalTrials.gov/EudraCT.
• Identifies and resolves problems related to the production of summaries and posting of results.
• Communicates with internal staff and appropriate external study contact(s) to obtain all relevant information needed to assure work is completed in accordance with the project schedule.
• Consults with internal/external clients to determine posting requirements and suggests/guides plans to accomplish these needs.
• May represent the department in inter-department and working groups.
• May be responsible for interacting with international study teams to ensure timely reporting of study results
• Assures management is informed of any problems or unresolved issues that could affect the timely completion of the work or the work quality.
• Perform other duties as assigned.
EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS
• Minimum 5-7 years’ experience working in a medical writing capacity, experience authoring clinical documents (i.e., Clinical Study Reports, Protocols, etc.) strongly preferred, experience performing CT.gov tasks preferred.
• Clinical/regulatory process experience or in a pharmaceutical environment a must
• Knowledge of ICH and GCP guidelines required
• Demonstrated ability to prepare and finalize clinical documents (i.e., Clinical Study Reports, Protocols, etc.)
• Good communication skills, both oral and written are mandatory in order to clearly, effectively, and tactfully interact with Client stakeholders
• International study experience a plus
• Demonstrated ability to be customer-oriented and to achieve high customer satisfaction levels
• Demonstrated ability to prioritize and manage multiple tasks
• Ability to attend to detail, think logically and critically evaluate and solve problems
• Demonstrated good judgmental and independent decision-making abilities, as well as strong follow-up skills
• Demonstrated team skills, professional values and personal skills necessary for effective teamwork
• Ability to work with multiple study teams in one or more therapeutic areas
• Computer literacy required
• Minimum Bachelor’s Degree with a science background required; advanced degree preferred
DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.
DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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