Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Medical Affairs Group

Job Sub

Function:

Medical Affairs

Job Category:

Scientific/Technology

All Job Posting Locations:

IN020 Mumbai Arena Space

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Medical education activities

Identify important medical activities in order to fulfil medical education and knowledge gaps as defined in medical affairs plan Work collaboratively and effectively with medical education team for development and implementation of all medical education activities including company-organized medical education, CME, educational grants or sponsor HCP to medical education events Take ownership in designing and leading Medical Advisory Boards. Take ownership and proactive approach in working with faculty for ensure high quality of scientific content

PRINCIPAL RESPONSIBILITIES may include but not limited to:

Define major accountabilities and/or activities. List most complex or difficult parts of job first and indicate percentage of time required to perform each task.

Key roles may be different country by country. So, % of time can be put at each OpCo level considering local situation.

TA Leadership - New Product Launches

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Be trusted scientific experts in the related TA -New Product Launches Be aware of latest scientific and clinical advances in relevant therapy areas. Know well and skillful in conducting literature search and good ability in reading and analyzing clinical papers to promote evidence/scientific-based brand concepts. Provide regular clinical & scientific knowledge sharing across the TAs and Brands Deliver medical insight into product Life Cycle management planning. Provide Medical expertise to marketing colleagues in product development team from the early development phase throughout the life of the product by identifying the optimum positioning of the product in the life of the therapeutic area. Provide expert medical leadership into issues management (e.g. product withdrawals, safety alerts etc.) Provide expert medical input into key market activities and regulatory body interactions Be responsible for monitoring medical spending and project costs.

Medical Strategy

Responsible for developing and implementing medical affairs strategy plan within therapy area through effective medical gaps analysis in clinical data, clinical care, knowledge and medical education gaps together with holistic understanding of customers insights (external and internal stakeholders) Close collaboration with key stakeholders from marketing, regulatory, access, medical education and clinical operations during local Business Planning and Strategic Planning, with overall ownership for the Medical Affairs component of a brand or business unit plan and ensuring medical leadership during Brand & Medical Cross Functional Team meetings to ensure alignment to Medical teams' objectives. Partner with medical education team and business partner for excellent execution of medical affairs activities as defined in medical affairs strategic plan.

Medical review

Responsible for Medical Affairs proactive input into the concept development of Brand promotional materials, artwork and final medical sign off /approval for each brand associated with the therapeutic area, ensuring alignment with Company standards and relevant POL/SOP on medical review Review and approval of promotional material, labelling information, package insert, training material for sales and marketing colleagues or other relevant documents, including reviewing translated medical document when needed.

Medical education activities

Identify important medical activities in order to fulfil medical education and knowledge gaps as defined in medical affairs plan Work collaboratively and effectively with medical education team for development and implementation of all medical education activities including company-organized medical education, CME, educational grants or sponsor HCP to medical education events Take ownership in designing and leading Medical Advisory Boards. Take ownership and proactive approach in working with faculty for ensure high quality of scientific content

Customer/External Interaction & KOL engagement

Develop and maintain scientific relationships with key thought leaders to build customer insight and develop strategic partnerships Meet with customers and researchers on a regular basis through meetings, conferences etc., to: Gather information and insights on therapy area (inc. Competitor landscape) and their medical and scientific needs Exchange disease area knowledge and opinions to understand the emerging opinions Increase the customers understanding of Johnson & Johnson products and processes (eg. clinical data, IIS, clinical trials, compliance processes), according to their expressed interests and needs and to seek their advice on the development of our products. Manage and maintain positive relationship with Key Opinion Leaders. Deliver scientific and medical content for medical advisory boards and medical education activities To be the point of contact for investigators proposing investigator initiated studies (IIS) and manage MAF studies (in collaboration with GCO) As requested business partners (e.g. Public/Communication Affairs, MKT), provide support in interacting with patient advocacy groups and their initiatives e.g. responding to clinical interest, gathering insights Establish and maintain contacts with external experts, participate in advisory committees and other professional relations activities and thought leaders within the territory and other countries where needed.
Develop and maintain productive relationships with relevant professional societies

Data generation

Work in collaboration with Regional Medical Affairs for post-registration medical data gaps and clinical trial needs and to drive the development of necessary protocols at local level Lead the development of study proposals for post registration company-sponsored local studies Accountable for the internal review and governance of Investigator Initiated Studies (IISs) Participate in study planning, e.g., with respect to evaluation of local business needs, timelines, grants and investigator/ site selection Participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel Support affiliate Clinical Operations, when needed, to address any questions and/or clarify issues arising during the conduct of studies, including Review and prioritise study protocols in consultation with GCO and Marketing with respect to local marketing goals, scientific merit and GCO resources. Advise or assist in the preparation of IRB submissions, including adaptation of international patient information sheets and consent forms to suit local requirements; Provide liaison between Marketing and GCO, interface with the local medical community both for local purpose (e.g. clinical teams, protocol writing, clinical plan design, brainstorms, advisory groups) and in support of international project.

Ensure External and Internal Compliance

Drive compliance through understanding, implementation and adherence to HCBI, global/regional/local SOPs, GSQA, local regulatory policy and industry codes of practice

Medical training

Provide Medical and Scientific training for internal stakeholders and external customers if required, including Sale and Marketing Colleagues as well as other relevant department.

Other important tasks

Provide MAF support in health economics with medical input as appropriate Medical information inquiry responsibility: Respond appropriately to unsolicited requests for information and/or data Be primary contact and responsible for Name Patient Programs conducted locally.

Internal collaboration & support

Participate in cross-functional (marketing, medical, regulatory, QA...) and input medical insights in brand team strategies. Additionally, highlight key aspects of the clinical data so that they form the basis of key marketing messages. Engage with internal stakeholders on topics of mutual interest in order to encourage optimal use and/or understanding of Johnson & Johnson products Build effective cross-functional working way and add value to business by Helping commercial colleagues in handling complex medical questions Field visit as a result of joint MKT/MAF decision Building KOL knowledge Recurrent medical questions/medical information inquiry handling

SPECIFIC COMPETENCIES/SKILLS REQUIRED:

Experienced in pharmaceutical industry is preferred Good understanding of clinical studies design and data Excellent communication in both writing and speaking Interpersonal communication skills Influence on other skills Strategic thinking mindset Ethical working approach with patient-centric focus

The role involves extensive interactions with

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Leading local and overseas specialists in different therapeutic areas Regional leadership team Other local management board members Health Care Compliance Sales and Marketing team in local Operating Company Global Clinical Operation/ Medical Affairs Operation (GCO/MAO) All Medical Team leaders and members Local Regulatory agency Local Scientific Association

30-40% travel to meet important stakeholders, gather insights and participate in key medical/scientific meetings/ congresses