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At Covance, your imagination, your dedication, and your drive to find solutions to challenging projects begin on your very first day. Covance is one of the world’s largest and most respected contract research organizations. Our clients are a Who’s Who of the pharmaceutical and biotechnology industry. If you’re looking for a diverse and stimulating work environment, you'll find it at Covance.

The Medical Writer is responsible for the production of study protocols, clinical study reports (CSRs), Investigator’s Brochures, and other documents as needed. Provides guidance and leadership to ensure successful project completion. Preparation and coordinating development of draft and final protocols, and protocol amendments for Phase I/II studies. Interpretation of clinical, pharmacokinetic, pharmacodynamic, and statistical results as appropriate for Phase I/II studies.

Duties and Responsibilities:
• Writes and coordinates the development of study protocols and protocol amendments of simple to intermediate complexity.
• Prepares scientifically valid draft and final CSRs (i.e., interim and abbreviated CSRs to fully integrated CSRs), including the scientific interpretation of data and writing of clinical, pharmacokinetic and pharmacodynamic results, discussion and conclusions, for studies of intermediate complexity conducted at Covance and other sites, in a timely and accurate manner in accordance with Covance/Client Standard Operating Procedures and regulatory requirements.
• May perform review of CSRs for content, presentation, scientific presentation and validity for allocated studies and resolves any issues with the Covance project team before the draft CSR is issued.
• Responds to Quality Assurance Audit and Client comments on the CSR, amends CSR as appropriate and incorporates review findings prior to dispatch of CSR to Client.
• May allocate resources to meet needs related to the production of CSRs and protocols.
• Identifies and resolves problems related to the production of CSRs and protocols.
• Reviews data listings and study data as appropriate, prior to database lock, for consistency and scientific integrity.
• Participates in the review of the draft and final statistical analysis plan (SAP), in cooperation with the Covance project team. Reviews SAPs for assigned studies to ensure the data presentation and analysis methodology are consistent with the study objectives.
• Communicates with internal staff and the external study contact(s) to obtain all relevant information needed to adhere to the project schedule.
• Consults with internal/external clients to determine their needs and suggests/guides plans to accomplish these needs.
• Provides guidance and leadership to the pharmacometrics project team to ensure successful project completion.
• May attend meetings with clients, and represent Medical Writing at audits as applicable.
• May represent the department in inter-department and working groups.
• Looks for ways to improve the efficiency and quality of work processes as appropriate.

Qualifications:
• BS or MS degree in Science/Medical field. Experience may be substituted for education.(PhD preferred.)
• 3 years professional related experience.