Science Writing Director, RDC
Site Name: USA - Maryland - Rockville, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence Posted Date: Jul 23 2021 US remote working may be considered Science Writing Director, RDC Are you interested in a highly visible role that gives you the opportunity to have a real impact on the development and delivery of GSK industry leading pipeline in a high-end scientific environment while managing a team in a multicultural setting? If so, this Science Writing Director role is an exciting position to explore. The Role: The Science Writing Director leads and manages a team of internal and third-party medical writers. The role applies experience, scientific and operational expertise, and leadership in a matrix organization to design and deliver high quality fit for purpose documents and key organizational process improvements including regulatory submissions. This role is responsible for the scientific content, quality and on-time delivery of end-2-end clinical and regulatory documents to support a variety of projects to deliver innovative vaccines. Key Responsibilities: Organizational Awareness: Strong understanding and ability to incorporate organizational considerations into strategic and operational decisions at the Research and Development Center. Create and gain commitment to a future vision. Ensure it is measurable at the level of the Research and Development Center and aligned with organizational goals. Lead through vision and values. Negotiation: Explore positions and alternatives to reach agreements and solutions. Present clear arguments to gain acceptance of ideas and influence outcomes to meet organizational objectives for the Research and Development Center. Judgment and Problem solving: Demonstrated track record of quality decision making and creative problem resolution that impacts program/project direction. Risk Taking: Make decisions when outcome is unclear; act with potential negative consequences. External Relationship, Influence and Communication: Leadership role in GSK's to implement external regulatory requirements (e.g., transparency initiatives). Demonstrate an ability to influence others, both internally and externally, to form beneficial partnerships to meet organizational objectives at the level of the Research and Development Center. Leadership and Expertise: Lead and manage a team of internal, contingent and/or contract medical writers to deliver the work specified above. Create opportunities to apply new skills and minimize barriers to development Team leader and expert medical writing consultant. Lead across assets of the Research and Development site,prioritising workload across an asset or group of assets to deliver MW portfolio. Lead matrix team in the delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data and are in line with GSK standards and global/regional/local regulatory requirements, while encouraging high performance standards across the matrix teams. Lead, drive, promote and implement key organizational process improvement initiatives. Proactively generate ideas for improvement taking advantage of opportunities that arise. Promote environment for others to generate ideas for improvement and embraces and champions innovations and ways of working. Lead development of training materials for clinical documentation and submission planning. Provide mentoring, coaching and/or training to individuals or teams. Matrix Teamwork and Function: Establish quality, efficiency and effective teamwork across all document teams. Prioritize and successfully meet deadlines across multiple project teams with attention to detail. Work closely with multifunctional Development teams, to provide significant contribution to complex clinical submission documents, document strategy and document delivery. Relationship, Influence and Communication: Build interactive relationships with team leaders and senior stakeholders. Demonstrate an outstanding track record of leading and influencing teams in a matrix environment. Promote team effectiveness across assigned projects. Build and maintain networks at project, departmental and inter-departmental levels; ensures timely dissemination of information to appropriate levels to improve transparency. Possess highly effective communication skills. Capable of clearly presenting ideas and data to a group, including key stakeholders at senior level or external formats. Motivate, influence, and advocate for medical writers, team members and senior stakeholders to effectively contribute to and review documents. Planning and Team Coordination: Able to develop resourcing strategies to meet project team objectives. Determine resourcing strategy to meet anticipated deliverables. Process Improvement and Compliance: Lead process improvement, training, quality and compliance through ideas, proactive action, and engagement. Third-Party and off-Shoring Resourcing Oversight: Lead off shoring and external resourcing and CRO interactions. Initiate and implement third party resourcing agreements and oversee contract medical writers and medical writers based in India assigned to a project at an Research and Development Center. Identify need for external resource support, negotiate timelines and cost with external medical writing vendors/CROs. Key Competencies: Oversight Ensure members have the capability to strategically develop scientific content of documents (through a variety of techniques) Ensure empowerment and accountability to plan and deliver documents on time Continually engage stakeholder departments, work with heads of stakeholder departments to identify risks and opportunities and socialize new initiatives (eg, ICF template) Agility to develop capabilities to meet new regulatory requirements (eg, redaction and plain language summaries) and innovate support to other departments (eg, Regulatory Affairs through clinical summaries and clinical overviews preparation) Identify risks to strategic, ethical or compliance objectives (eg, to article 46 compliance or delivery of a critical-path documents needed to deliver our pipeline) Resourcing strategy: Identify global requirements through monitoring of activity and risks (eg, identify activities and interaction between in-house local and remote, contingent, third party partners) Capability building (eg, develop writers to enhance communication to the patients) Accountable for Scientific Writing support Measure and monitor efficiency, quality (incl. consistency) and scientific integrity of writing. Ensure good writing practices and fluid communication within study teams Ensure appropriate leadership/ownership by all levels of writers on the clinical project teams to enable the optimal planning for delivering strategic objects (esp. for producing critical documents). Drive/create state of the art practices to meet increasingly stringent regulatory requirements and competitive environment. Team management Manage the team of GSK Biologicals Scientific Writers and ePublishing. Coordinate work of the Scientific Writing. Hire, integrate and develop newcomers. Ensure third party partners are properly integrated into teams Why You? Basic Qualifications: • PhD in Life Science. • Significant experience in Scientific Writing in a clinical setting within the pharmaceutical industry. • Leadership, ownership and accountability. • Experience in multicultural settings, diverse environments with respect to dynamics of human interaction. • Project and people management skills. • Negotiation skills (to propose creative solutions to new challenges). • Strategic, planning and organizational skills. • Outstanding knowledge of written and spoken English • Ability to mentor and understand selection of essential information, logical flow, clarity, accuracy appropriate for target audiences (eg, scientific community, regulatory bodies, patients, general public). Preferred Qualifications: • Strategic thinking • Lead/influence within matrix clinical project teams • Alignment with matrix clinical project teams • Complex resource management (external collaborators, off-shore, in-contracted CRO staff). • Ability to establish network of communication • Ability to work with remote teams Why GSK? GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose - along with our goal of being one of the world's most innovative, best performing and trusted healthcare companies - helps us attract some of the best and brightest minds in the world. We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK; in the way we do business; and in the communities where we operate. We want our company to be a place where diversity of people and thought is valued everywhere and where we're all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission. Reinforced by our clear values and expectations, it is part of our DNA. Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day. If you require an accommodation or other assistance to apply for a job at GSK/ViiV Healthcare, please contact your local HR department. GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.