Medical Writer III

Description:

The Medical Writer is responsible for providing medical writing ensuring successful preparation of high quality documents and effective implementation of the writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with cross-functional groups to ensure accurate and timely completion/delivery of information and review of writing projects.

Serves as medical writing lead on assigned projects. Works closely with in-function and cross-functional teams on project strategies. Implements all activities related to the preparation of writing projects

Coordinates the review approval and other appropriate functions involved in the production of writing projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.

Converts relevant data and information into a form that meets project requirements. Explains data in manner consistent with the target audiences requirements.

Effectively communicates deliverables needed writing process and timelines to team members. Holds team members accountable to agreed-upon project dates and with an appropriate quality level.

Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands. Identifies and proposes solutions to resolve issues and questions arising during the writing process including resolution or elevation as appropriate.

Understands assimilates and interprets sources of information with appropriate guidance/direction from development teams. Interprets and explains data generated from a variety of sources. Verifies that results are consistent with protocols.

Challenges conclusions when necessary. Understands/complies with appropriate conventions proper grammar usage and correct format requirements as needed for each writing project following applicable divisional guidelines templates and SOPs.

Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to writing project.

Works with journal/congress throughout the writing process addresses questions/feedback as appropriate and works with team to draft responses as necessary.

Knowledgeable of US and international regulations requirements and guidance associated with preparation of writing projects. Learns and applies knowledge of therapeutic area and product to writing projects. Must continually train/be compliant with all current industry requirements as they relate to assigned projects including submission/approval standards.

Serves as a representative on project teams. Acts as Subject Matter Expert regarding computer-based technologies utilized by the respective departments. May mentor and provide guidance to more junior medical writers and/or external vendor/agencies. Implements tactical process improvements.

Skills:

Medical Writing, Publications, Poster Presentations, Peer Reviewed Journal, Clinical Research, Regulatory Affairs, Pharmaceutical, FDA, ICH, GCP

Top Skills Details:

Medical Writing,Publications,Poster Presentations,Peer Reviewed Journal

Additional Skills & Qualifications:

PhD in Science

1-5 Years of Medical Writing experience from a PhD Program, Post Doc or Industry position

Experience with authoring publications, peer reviewed journals, and poster presentations related to scientific and medical literature

Experience Level:

Entry Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.