Primary Role:
The Medical Writing Group Lead (Dir) is responsible for strategically planning and resourcing the medical writing deliverables that support Shire business objectives across a large therapeutic program or multiple programs. The MW Group Lead independently provides strategic direction to cross-functional project teams to ensure that clinical documents (eg, investigators' brochures, study protocol and amendments, study reports, marketing authorization submission documents) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements. The MW Group Lead writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and accurate data presentation and interpretation.
As a member of the MW Leadership Team, the MW Group Lead contributes to the strategic direction of the department and mentors less experienced writers. The MW Group Lead initiates and leads initiatives designed to establish best practices and efficient cross-functional collaboration. The MW Group Lead has direct people management responsibility including performance management, skill development, and fostering a BRAVE culture. In addition, may be responsible for budget and resource allocation pertaining to MW activity.
The MW Group Lead reports to the Head of Medical Writing.
Responsibilities:
35%: Writing, most often the more strategic documents to support the goals of the product(s)/program(s).
15%: Directing and mentoring MW team members (internal and external) ensuring quality and efficiency in the production of clinical regulatory documents.
25%: Overseeing the medical writing aspects of the program(s), attending strategic meetings, developing timelines, assessing resource needs, collaborating with cross-functional colleagues
20%: Leading or participating on departmental or cross-functional initiatives including actively participating on the MWLT
5%: People management activities including performance management, people development, and fostering a BRAVE culture.
Education & Experience Requirements:
* Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor's degree required.
* 14+ years experience in clinical/pharmaceutical development with directly related medical writing experience.
* At least 5 years of direct line management experience.
* Global regulatory submission experience required.
Other Job Requirements: Less than 10% travel (domestic or international).
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.
Application URL:http://www.aplitrak.com/?adid=YXN0YW5pdHMuMjI1MDkuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20