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Medical Writing and Clinical Submission Planning Director

Employer
GlaxoSmithKline
Location
UK
Salary
Competitive
Closing date
23 May 2022

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Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
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Site Name: USA - Pennsylvania - Upper Providence, UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Philadelphia
Posted Date: Dec 17 2021

Medical Writing & Clinical Submission Planning Director - Oncology

As a Medical Writing & Clinical Submission Planning Director you will work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements.

In the US, this position can be based at the GSK Collegeville, PA or Waltham, MA locations and can be remote based within the east coast time zone.

Job Purpose and Key Responsibilities:

Apply experience, scientific and operational expertise, and leadership in a matrix organization to design and deliver high quality fit for purpose clinical regulatory documents and key organizational process improvements including regulatory submissions.

  • Leadership and Expertise:
  • Team leader and expert medical writing consultant.
  • Lead one or more assets and serve as a medical writing point of contact for this/these assets.
  • 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 demonstrating high performance standards for own work and encouraging similar 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 champions improvements in technology 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. 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 document and 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 in the matrix team.


  • Third-Party Resourcing Oversight:
  • Lead external resourcing and CRO interactions.
  • Initiate and implement third party resourcing agreements and oversee contract medical writers.
  • Identify need for external resource support, negotiate timelines and cost with external medical writing vendors/CROs.


Role may include:
  • Managing Direct Reports and Developing Organizational Talent
  • 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.


Basic Qualifications:
  • Basic: Bachelor's degree in life sciences


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Master's degree in life sciences.
  • Relevant professional experience.
  • Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome).
  • Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions.
  • High-level technical, statistical skills.
  • Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas).
  • Possess highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at a senior level.


Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally
  • Developing people and building a talent pipeline
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally
  • Budgeting and forecasting, commercial and financial acumen.

*LI-GSK

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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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.
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