Standards & Compliance Manager

Year    Bengaluru, Karnataka, India

Job Description

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Site Name: Bengaluru Luxor North Tower
Posted Date: Feb 23 2024
Are you looking for a leadership role that allows you to shape and accelerate scientific communications and enhance the medical writing process? If so, this Scientific & Medical Writing Director role could be an ideal opportunity to explore. As a Scientific & Medical Writing Director, you will be responsible for applying scientific and operational expertise, and leadership in a matrix organization to design and deliver high quality, fit for purpose clinical documents and key organizational process improvements relating to clinical documents including submissions. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following\xe2\x80\xa6
  • Effectively lead matrix team in the delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data and are in line with standards and global/ regional/local regulatory requirements.
  • Accountable for developing and implementing plans for document delivery and/or lifecycle.
  • Lead medical writing aspects of review of reporting and analysis plans and provides critical input on required tables acting as key contributor to regulatory responses as necessary.
  • Implement strategies to manage implications and risk on clinical submission timelines, budgets and goals.
  • Motivate, influence, advocate for and manage direct reports, complementary staff, contract workers, other team members and senior stakeholders to effectively contribute to and review documents.
  • Promote environment for others to generate ideas for improvement and champions improvements in technology and ways of working.
  • Lead development of training materials for therapeutic area scientists and provide mentoring and/or training on clinical documentation and submission planning to individuals or teams.
  • Identify need for external resource support, negotiate timelines and cost with external medical writing vendors/Clinical Research Organizations (CROs).
  • Prioritize effectively managing multiple deadlines across multiple project teams successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix teams.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor\xe2\x80\x99s degree
  • Experience leading medical writing projects or programs
  • Experience leading activities or components of a project/program to meet business and regulatory submission needs
  • Scientific or medical writing experience specifically within the biotech/pharmaceutical industry

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Advanced Degree in Life Sciences
  • Excellent verbal and written communication skills
  • Ability to work independently and make decisions with minimal supervision
  • Proven ability to influence and negotiate with key internal and external stakeholders or partners

Why GSK?

Our values and expectations are 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 \xe2\x80\x93 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.
  • This is a job description to aide in the job posting, but does not include all job evaluation details.
Why Us? GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in \xe2\x80\x9cgsk.com\xe2\x80\x9d, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.

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Job Detail

  • Job Id
    JD3253648
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Bengaluru, Karnataka, India
  • Education
    Not mentioned
  • Experience
    Year