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Job Requirements of Associate Director - Medical Writing:
-
Employment Type:
Contractor
-
Location:
San Francisco, CA (Onsite)
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Associate Director - Medical Writing
Careers Integrated Resources Inc
San Francisco, CA (Onsite)
Contractor
Job Title: Associate Director - Medical Writing
Job Location: San Francisco, CA
Job Duration: 10-11 Months (possibility of extension)
Pay Range: $90 - $115/hr. on w2
Job Summary:
Duties and Responsibilities:
Education:
Experience:
Knowledge, Skills and Abilities:
Job Location: San Francisco, CA
Job Duration: 10-11 Months (possibility of extension)
Pay Range: $90 - $115/hr. on w2
Job Summary:
- This position will report to the Medical Writing Department Head and will lead scientific, medical and regulatory writing activities for development projects, ensuring full life-cycle support from clinical study protocols through regulatory submission and post-approval activities, and that documents are written in compliance with all regulations (ICH, GLPs, and GCPs).
- The professional will also perform the medical writing, QC reviews, and editing of the documents and will be responsible for the management, planning and direction of a team of medical writers.
- The professional will ensure the timely presentation/dissemination of clinical data from investigational pipeline products according to budget, timelines, strategic publication plans, and tactical approaches; and ensures that strategically aligned scientific communication points are delivered and that statements and conclusions in publications (manuscripts, abstracts, posters, oral presentations, etc.) are accurate and supported by appropriate data.
- This job contributes to and supports the company’s research and development efforts to create high value therapeutics to address medical needs.
Duties and Responsibilities:
- Manages all clinical writing activities outlined in the Project Clinical Development Plans
- Reviews documents, offers guidance, and takes lead in creating and managing the document timelines in the preparation of regulatory and publication documents
- Organizes, conducts, and leads document production meetings and other meetings as necessary. Creates the agendas and minutes to document meetings according to SOPs
- Manages the oversight of CT.gov updates and when required enters CT.gov updates directly into the system including data entry when necessary
- Projects Medical Writing assignments, resource allocation, and timeline requirements for CDP
- Responsible for implementing the departmental guidelines, writing style guide and departmental templates such as, protocols, investigator's brochures, final clinical study reports, and IND sections
- Remote work, must be available PST time zone but offsite location is flexible.
Education:
- A Bachelors/Masters degree in a scientific discipline with a strong medical writing background is required. PhD. in a scientific or life sciences discipline preferred.
Experience:
- A minimum of 10 years in a pharmaceutical, biotech, or CRO medical writing position is required.
- A minimum of 8 years writing management experience is also required.
- A minimum of 10 years previous supervisory experience is required.
- Demonstrated experience as a primary author writing protocols, IBs, CSRs, IND/NDA sections and other regulated documents.
Knowledge, Skills and Abilities:
- Knowledge of regulatory functions, FDA and ICH guidelines for various scientific documents. Knowledge of CTD format.
- Strong analytical and strategic thinking skills with the ability to implement.
- An ability to create effective presentations from raw data is essential.
- An ability to interpret statistical and clinical data is essential.
- Must have an ability to work well with others in high-pressure situations.
- Must have demonstrated problem solving abilities.
- Strong organizational skills are required.
- Experience managing CT.gov and other registries for clinical trials
- Strong written and verbal communication skills are required.
- An understanding of clinical research, biostatistics, and regulatory affairs is required.
- Excellent computer skills are required.
- Working knowledge of MS word, Excel, Power point is required. Client template and Please Review experience preferred.
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