Project Coordinator Contractor Ii

job summary:

As the world’s largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you’re looking for a position where you can serve as an asset to your company while making a difference in others’ lives, we have the ideal position for you!

location: Telecommute

job type: Contract

salary: $35.91 – 42.25 per hour

work hours: 9 to 5

education: Associate

responsibilities:

Duties:

The Project Coordinator, Medical Writing will provide project management support for Global Medical Writing deliverables across all studies, molecules and programs. Through exceptional organizational and communication skills, the Project Coordinator will work with in-house, contract medical writers, and vendors to ensure the on-time delivery of high-quality clinical regulatory documents, including but not limited to, study reports, clinical study protocols or amendments, investigator brochures, and clinical sections of INDs, NDAs, BLAs, and MAAs.

qualifications:

Skills:

• Planning, tracking, and managing the progress of all documents supported by the Global Medical Writing department via continuous communication with the medical writers (in-house or contract), Quality Control (QC) specialists, and cross functional teams; provide input to medical writers to aid the development of document timelines, as needed
• Collaborating with senior management and other Project Coordinators to assign writers and personnel in the Global Medical Writing department to documents, considering a variety of factors such as availability, location, expertise, familiarity with a program, study or team, etc
• Liaise with internal and external key stakeholders, including attending study team or other meetings as needed to obtain information regarding requests for Medical Writing support before medical writers are assigned
• Identify and resolve issues and conflicts on documents; provide recommendations to medical writers and QC specialists on how to meet deliverable milestones, if delays or issues are encountered
• Support budget and resource planning for the Global Medical Writing department; proactively communicates to senior management any upcoming timeframes where additional Medical Writing resources might be needed
• Assist with Quality Control assignments, as well as Medical Writing Department contracts/invoices as needed
• Contribute to the development and refinement of processes and procedures within the Global Medical Writing department, championing improved efficiency, quality and performance

Required Skills:

CLINICAL RESEARCH

CLINICAL STUDY

MEDICAL WRITING

PROJECT COORDINATOR

BUDGET

Additional Skills:

CLINICAL REGULATORY

CONTRACTS

INVOICES

LIFE SCIENCES

PHARMD

PROJECT MANAGEMENT

QUALITY CONTROL

REGULATORY DOCUMENTS

Education:

Associates Degree or Bachelor’s Degree in Project Management, Life Sciences or other related area required; PhD/PharmD or other graduate-level degree is a plus.

Ideally 2+ years of relevant industry or clinical research experience; familiarity with the Medical Writing function is a plus

skills: Quality control, Clinical research

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate’s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

For certain assignments, Covid-19 vaccination and/or testing be required by Randstad’s client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.