Job Description

Title: Senior Regulatory /Medical Writer

Duration: 12+ Months

Location: San Rafael CA 94903 ( 1-2 Days Onsite/Week)

Seeking candidates who are regulatory medical writers (not Medical Communication)

• The Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

Responsibilities:

• Drafts and edits documents used for submissions including CTDs and RtQs
• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PSURs, DSURs, etc.)
• Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
• Works effectively with cross-functional groups within client.
• Other tasks as assigned.

Contacts

• Clinical Medical Writing, Biostatistics, Clinical Data Management, Statistical Programming, Clinical Operations, Medical Affairs, Medical Directors, Regulatory Affairs, Legal, Commercial, Pharmacology/Toxicology, Corporate Compliance, Project management, Pharmacovigilance.

Equipment

• Access to corporate computer network, production computing environment, and MS Windows software.

Skills:

Fulfills one of the following:

• Medical writer in the pharmaceutical industry
• Medical or scientific writing experience as a primary job responsibility
• Skill and Experience: At least 6+ years experience required
• Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
• Familiar with clinical study data collection and results reporting.  Previous protocol development experience required.
• Experience writing, reviewing, or editing protocols and clinical study reports highly preferred.
• Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred.
• Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
• Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.
• Ability to interpret basic tabular and graphical clinical data presentations.
• Ability to create basic tables using AMA style (eg, Schedule of Events).
• Intermediate applied knowledge of basic clinical laboratory tests.
• Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
• Basic understanding of biostatistical and clinical research concepts. Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint.
• Experienced with scanners, printers, and copiers. Basic knowledge of regulatory requirements and guidance associated with ‘standalone’ regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
• Capable of working on multiple tasks and shifting priorities. Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation. Good conflict management skills. Motivated and shows initiative.
• Detail oriented. Capable of well organized, concise and clear written and verbal communication. Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
• Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.

Education:

• Bachelor’s or higher degree; scientific focus desirable.
• Evidence of medical writing career development desirable, eg, American or European Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

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