OVERVIEW

We are currently searching for a skilled professional to join a well-known client's team as a remote Director of Medical Writing and Medical Affairs. The Director of Medical Writing and Medical Affairs will Design and implement the functional Medical Affairs strategy plan, oversee IIS and expanded access programs, lead publication strategy, lead the writing of selected publications and Grant applications.

Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Design and implement the functional Medical Affairs strategy plan, oversee IIS and expanded access programs, lead publication strategy, lead the writing of selected publications and Grant applications.
• Oversee the Strategy plan and implementation of scientifically sound Investigator Initiated Studies, manage publication planning and execution to ensure that all data generated is publicly presented in an appropriate and timely fashion and in a fair and balanced manner, and oversee the single patient IND initiative.
• Responsible for Medical Advisory Boards, Publications, Scientific Training and Letters and Medical Information.
• Work closely with Commercial and Clinical Development to develop medical launch strategy for pipeline assets.
• Review and interpret data from clinical studies, including submission of abstracts to scientific meetings, presentation of results, and submission of journal articles for publication.
• Interface with internal research and business development teams and with external academic and governmental scientists and clinicians.
• Educate physicians about Direct Biologics' medicines; and recruit, mentor and motivate talented professionals.
• Foster productive relationships with Key Opinion Leaders (KOLs) - Represent Direct Biologics at medical meetings, advisory boards, and in interactions with KOLs.
• Document creation areas include Federal/State grants and contracts, scientific/clinical publications, and intellectual property pursuits.
• Take leadership role on projects, as requested, or needed, to drive to completion.

EXPERIENCE

• Proven ability to successfully network with subject matter experts.
• Excellent clinical judgment, strong organizational abilities, credibility and leadership skills.
• Excellent decision-maker, with proven success at making timely decisions to move forward.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Can effectively review a statistical analysis plan and to identify deficiencies, errors, and
• inconsistencies in statistical output.
• Can integrate, interpret, and summarize data in a clear and concise manner.
• Ability to effectively manage multiple tasks and projects.

EDUCATION

• Advanced Degree in life sciences, PhD preferred is required (PhD preferred, MD, PharmD)
• At least 5 years of experience in Medical Affairs is preferred.
• Medical Writing experience, a history of publications is necessary.
• In-depth knowledge of drug development, medical writing, and associated regulations.
• Demonstrable experience and familiarity with grant writing and grant submissions.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.