Years of Experience: 6-10 years
Skill Set / Exposure: Clinical Pharmacology background, CTD submission Modules / Regulatory Writing
Location: Bangalore
Mode: Hybrid Mode (3-4 days office)
Mode of Interview: MS Teams Virtual interviews
About the Position:
- Are energized by a medical writing role that allows you to shape operational strategy and accelerate product approvals? Do you have experience in clinical pharmacology? If so, this Associate Director Medical Writing Asset Lead role could be an exciting opportunity to consider.
- As an you Associate Director Medical Writing Asset Lead, you will implement operational strategy guided by the Therapeutic Area Head of Medical Writing, tracking milestones and deliverables to manage the performance of the Medical Writing team, ensuring consistency, regulatory compliance, and high quality of functional deliverables.
- You will apply experience, scientific and operational expertise, and leadership in a matrix organization to provide Medical Writing strategy to one or more therapeutic area assets, to design and deliver high-quality fit for purpose clinical documents including those for regulatory submissions, to plan for efficient and accelerated ways of working, and to contribute to key organizational process improvements.
- This is a highly visible medical writing role, that will provide YOU the opportunity to lead key activities to progress YOUR career.
Leadership and Expertise:
- Medical writing lead for one or more medicines and/or vaccine assets throughout the live cycle of drug development, with a focus on clinical pharmacology.
- Provide the medical writing strategy for the development of clinical programs and content of documents.
- Lead matrix team to deliver 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.
- Clinical documents in scope include clinical study protocols, clinical study reports, briefing documents for regulatory authorities, Common Technical Document Summaries (m2.7.1/m2.7.2), clinical overview, ethnic sensitivity analysis reports, responses to regulatory authority questions, clinical sections of the IMPD/IND for clinical trial applications, Investigator Brochures.
- Collaborate with in house, CROs and/or independent contractor medical writers to ensure on-time delivery of high-quality fit for purpose documents. Collaborate closely with Global Regulatory Affairs and other cross-functional groups to understand business needs and clinical data.
- Demonstrate high performance standards for own work and encourage similar standards across the matrix team.
- Ensure Medical Writing strategy is aligned with the portfolio strategy (e.g., prioritization, acceleration, meeting upper quartile performance). Provide guidance and facilitation to submission teams in development of submission plans. Recommend solutions for problems that affect timelines.
- Drive, promote and implement key organizational process improvement initiatives. Proactively generate ideas for simplification and improvement taking advantage of opportunities that arise. Promote environment for others to generate ideas for improvement (e.g., continuously challenge the status quo) and champion novel business solutions in technology and ways of working.
- Lead development of training materials for a range of clinical documents. Provide mentoring, coaching and/or training to individuals or teams to develop others and share learnings.
- Promote leadership behaviors that support GSK values. Provide resourcing information to Medical Writing Therapeutic Area Head to contribute to budget forecast, escalate risks and opportunities to ensure optimal resource utilization and timely product approvals.
Matrix Teamwork and Function:
- Establish quality, efficiency, and effective teamwork across all clinical document teams.
- Work closely with stakeholders to provide significant contribution to complex clinical submission documents, document strategy and on time, efficient document delivery.
Relationship, Influence and Communication:
- Lead and influence teams in a matrix environment. Promote team effectiveness across assigned projects. Build and maintain networks at project, departmental and inter-departmental levels. Ensure timely dissemination of information to appropriate levels to ensure transparency and shared learnings.
- Ensure effective communication, including clear presentation of ideas and data to a group, which may include key stakeholders at senior level or external opinion leaders.
- Influence and advocate for medical writers, team members and senior stakeholders to effectively contribute to and review documents.
- Support a culture of open and honest conversations, smart risk taking, decision-making, and pushing the performance edge within Medical Writing and in cross-functional platforms.
- Be pragmatic with strong negotiation skills (to propose creative solutions to new challenges).
- Continually engage stakeholder departments, work with stakeholder departments to identify risks and opportunities, and socialize new initiatives (e.g., new templates and processes).
Planning, Organization and Team Coordination:
- Able to develop and implement study and above study document and resourcing strategies to meet project team objectives and anticipated deliverables.
- Able to develop a resourcing plan to enable efficient and accelerated delivery of documents and submissions.
- Flexibility to adjust plans when project timings change.
Process Improvement and Compliance:
- Support process improvement, training, quality and compliance through ideas, proactive action, and engagement in the matrix team.
Additional Job Responsibilities:
- Identify risks to strategic, ethical or compliance objectives (e.g., article 46 compliance or delivery of a critical-path documents needed to deliver our pipeline) and put in place appropriate mitigation strategies.
- 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 of writers on the clinical project teams to enable the optimal planning and delivery of documents (esp. for producing critical documents).
- Drive thorough submission planning and delivery with application of agile, efficient and accelerated processes as needed.
- Resource management.
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- PhD, PharmD, MPH, MSc, or other post-graduate degree.
- Experience in clinical pharmacology.
- Proven track record in writing clinical documents in scope.
- 6+ years’ experience in clinical regulatory writing in the pharmaceutical industry.
- 6+ years’ experience in project management, planning, communication, and matrix leadership.
- 6+ years’ experience working with International Council for Harmonization (ICH)/Good Clinical Practice (GCP) Guidelines.
Preferred Qualifications:
- If you have the following characteristics, it would be a plus:
- Experience in modelling and simulation, immunogenicity, biomarkers, and virology.
- Highly effective communication skills and capability to present ideas and data clearly to a group, including key stakeholders at senior level.
- Demonstrated track record of quality decision making and creative problem resolution that impacts program/project direction.
- Experience analyzing complex scientific & operational information and implementing effective solutions.
- Experience in Risk Management and Management Monitoring.
- Effective ability to prioritize tasks and deliver on deadlines.
- Proven track record of successfully managing simple to medium complex programs.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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