Total 22 Manager Corporate Affairs Executive job vacancies in Health / Beauty / Fitness category in Malaysia

The Candidate will be responsible to set up the Medical Affairs of NUHS@Home, develop strategies to enhance the effectiveness of its clinical quality program within the organisation and to identify and work on developing quality models, design and implementation of audits and risk management activities.

Job Responsibilities

Primary Responsibilities and Duties (80%)

- Set up and run the following QA and clinical services committees in functions such as organising meetings, preparing relevant reports for meetings, recording minutes, and ensuring that follow-up actions are taken after the meetings.

Not limited to:

• Clinical Committee which may comprisePharmacy, Therapeutics and Medication Safety Committe
  Credentialling and Privileging Committee
  Clinical Services, Medical Device and Procedures Committee
  Clinical Pathways Committe
  Antimicrobial Stewardship Committe
  Clinical Ethics Committe
  Infection control Committee
  
• Risk Management Committee which may compriseMortality, Morbidity and Peer Review Learning Committee
  Patient Safety Committee
  

- For clinical performance measurement:

• Monitor and collate data forHospital-wide Dashboard
  Healthcare Performance Office
  QIP indicators - hospital wide clinical quality indicators
  Other indicators
  
• Collaborate closely with relevant data/ operations teams to ascertain the precision and validity of data, facilitating the timely submission of the performance indicators report to the Ministry of Health.

- Ensure that drafts for new or revised clinical forms, e.g., consent forms and clerking forms, are vetted by hospital lawyer if necessary and approved by GCMB/ Clinical Lead in a timely manner.

- Conduct JCI / ESS (or equivalent) activities.

- Conducting clinical audits for various clinical work processes, case notes audit / review, audits on problem cases and ad-hoc audits.

- Oversee the monitoring of mortality and morbidity reporting ensuring 100% reporting rate.

- Compile and analyse data and generate annual reports.

Secondary Responsibilities and Duties (20%)

- Coordinate activities for Hospital Licensing Exercise and serve as liaison person for any queries on hospital licensing. (if required)

- Assist in preparing budget proposal (if required)

- Other Medical Affairs Activities

• Prepare presentations for HO / MO orientation (if required)

- Prepare papers for Medical Board, NUHS Board and MOH as and when required.

- Any other assigned duties.

Job Requirements

- Possess Bachelor’s degree with experience in a hospital setting

- Experience in Quality Management/Assurance in an acute care hospital will be an added advantage

- Computer skills in Words, Excel, Access and PowerPoint

- Basic statistical skills

- Keen interest in developing databases and reports relating to clinical QA

- Strong interpersonal skills, be meticulous, self-initiated and independent

Representing a leading force in the pharmaceutical industry, our client is dedicated to pioneering life-saving therapies. We are currently seeking a talented Regulatory Affairs Manager to join their team, where you'll play a pivotal role in leading regulatory efforts. This position requires a blend of technical expertise and strategic acumen to navigate approval submissions and oversee lifecycle management for groundbreaking pharmaceuticals.

MAIN RESPONSIBILITIES

• Develop and implement regulatory strategies for assigned pharmaceutical products, ensuring alignment with global standards and regulations.
• Efficiently manage the lifecycle and submission pipelines, maintaining adherence to time constraints.
• Act as the primary liaison with regulatory authorities, addressing inquiries and managing communication on regulatory issues.
• Stay abreast of evolving regulatory requirements, guidelines, and trends to inform and adapt regulatory strategy.
• Collaborate with internal stakeholders to align regulatory strategies with business objectives.
• Contribute to the development of the company's long-term regulatory strategy, identifying emerging trends and proposing proactive solutions.
• Ensure compliance with ethical, legal, and regulatory standards.
• Play a key role in maintaining the regulatory database, ensuring timely updates of regulatory information.
• Develop plans for regulatory compliance and product labeling, providing guidance throughout the product introduction process.
• Keep informed about changes in regulatory requirements in relevant countries.

QUALIFICATIONS

• Relevant Bachelor's Degree (Bachelor's Degree in Pharmacy is an added advantage).
• Minimum of 5-7 years in the pharmaceutical industry, with a focus on innovative pharmaceutical pipelines, particularly in oncology and rare diseases.
• Proven track record of regulatory successes in end-to-end new drug/generic applications.

Note: Candidates demonstrating aptitude, a strong desire to learn, and adaptability may be considered, even if they don't meet all the specified requirements.

ESSENTIAL QUALITIES

• Strong analytical skills to assess complex regulatory requirements and develop effective compliance strategies.
• Excellent communication skills to collaborate with cross-functional teams and communicate regulatory updates at all organizational levels.
• Detail-oriented mindset to ensure accuracy and completeness in all regulatory documentation and submissions.

HOW TO APPLY

Apply with your latest CV, detailing your relevant key achievements in regulatory affairs. We look forward to a confidential discussion about your potential role in our distinguished company.

Principal Consultant: Cheong Yee Yin

Registration Number: R22108633

EA License Number: 17C8502

Highlights

• Bachelor Degree in any discipline
• 2 years of relevant working experience (dental healthcare operations)
• Pleasant disposition, excellent interpersonal and communication (verbal and written) skills
• Strong analytical, people management and problem solving skills
• Ability to work independently and as a team with team leading experience
• Proficient in Microsoft Office applications
• Located at Jurong East

Job Responsibilities:
Manage feedback and complaint cases

• Overseeing the follow up of feedback and complaints on clinical matters
• Overseeing the handling of medico-legal complaints to ensure proper investigation and input from staff concerned and where relevant, seeking views and opinions from specialists.
• Co-ordinate with lawyers, Medical Insurers and where relevant, Dental Officers/Dental Surgeons’ insurers to ensure closure of case, after addressing concerns of patient and family members.

Manage clinical related issues

• Manpower related issues raised by Dental Heads
• Assist in coordination of renovations
• Inventory control
• Procurement
• Coordinate and prepare for DOPEX changeover
• Oral Health Promotion

Policies and Procedures

• Maintain JCI / ISO documents.
• Review and prepare policies, procedures and work instructions for clinical processes in order to facilitate patient safety and quality care.

Prepare and update reports, minutes and presentation slides

• Coordinate meetings (include logistics and booking of venue) and writing of minutes

Dental Intranet

• Maintain and update information on intranet

(A) JOB SUMMARY

You are responsible for medical affairs and clinical matters for the hospital, which includes:

1. Providing support to the Medical Advisory Board and Continuing Medical Education Committee.

2. Oversees Doctors’ Accreditation and Credentialing, and Re-accreditation matters and to ensure that all doctors’ accreditation status is updated timely.

3. Manages medico-legal matters and Serious Reportable Events promptly and according to timeline.

(B) PRIMARY DUTIES & RESPONSIBILITIES

1. To be the secretariat for Medical Advisory Board meetings, which include scheduling of meetings, minute taking and any other related matters in accordance with the Terms or Reference.

2. To be the secretariat of any ad-hoc Quality Assurance Committee (Including Committee of Inquiry) that may arise from time to time when there are cases for deliberation and discussion within the Medical Advisory Board and its subcommittees.

3. Risk manage and de-escalate medico-legal matters and Serious Reportable Events (SREs), including but not limited to:

a. Clinical Cases

• Maintaining records and data of medical incidents to:
• Summarize the information gathered from all stakeholders and prepare both preliminary and final reports (incorporating the views of expert opinion and legal advice provided) on the position adopted by the hospital and its rationale.
• Corresponding appropriately with hospital’s appointed legal advisors.
• If necessary, submit the MARSH report form to the hospital’s appointed insurers as and when necessary.
• Submit data timely to the National Quality Assurance System (NQAS) according to the stipulated timeline for all SRE cases.
• For medico-legal cases, to monitor and respond timely to all enquiries and follow-up actions from hospital appointed legal advisors or any other parties involved.
• Ensure prompt communication to patient or their next-of-kin as and when required.

b. Management of queries relating to Clinical Operations

• Respond to queries relating to Clinical Operations policies from both internal and external parties and maintain the query database.
• Assist in the preparation for any MOH Licensing and Accreditation Audits.
• Timely submission of data into Healthcare Application and Licensing Portal (HALP).
• Follow-up closely with all stakeholders for data submission prior to hospital inspection for Annex A submission and preparing Annex B for actual inspection.

4. Work closely with Quality Management Department for smooth hospital inspection by the MOH team.

5. Keep close tracking for all incoming emails from MOH and disseminate timely to Senior Management and all stakeholders for follow-up actions.

6. Work closely with Administrative Executive to administer Doctor’s applications for Accreditation and Credentialing and Re-accreditation including maintaining the master files and database of the accredited doctors to be updated timely. Ensure that all licenses, memberships, and certificates are renewed and valid at all times.

7. Support Doctor’s engagement and relationship building, including the administration of Continuing Medical Education (CME) activities such as organizing of medical talks / seminars / workshops for doctors and CME points submission.

8. Disseminate timely notification to doctors when there are urgent updates on hospital’s matters such as disruption to pharmaceutical items, etc.

(C) SECONDARY DUTIES & RESPONSIBILITIES

1. Any other duties and responsibilities that may be assigned by the Reporting Officer and company from time to time based on the company’s needs.

2. To take on any other special projects as assigned.

(D) KEY JOB SPECIFICATIONS

• Relevant tertiary qualification. Degree in any disciple.
• Medical / Nursing / Healthcare Management degree preferred.
• Minimum 5 years of relevant experience in healthcare services managing medical affairs portfolio preferred.

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Why Us

Illumina are a global leader in genomics – an industry at the intersection of biology and technology. At the most fundamental level, we enable our customers to read and understand genetic variations. We strive to make our solutions increasingly simple, more accessible, and always reliable. As a result, discoveries that were unimaginable even a few years ago are now becoming routine – and are making their way into patient treatment.

Why you

Are you passionate about improving patient outcomes and leveraging genetic testing to make a tangible difference in their lives? If so, this Regional Sr Medical Affairs Manager role offers an unparalleled opportunity to turn your passion into impact across Europe.

The role

As a Regional Sr Medical Affairs Manager you will work with the Medical Org functions, Marketing and the local Account Managers, as well as Customer Support and Strategic Growth teams in region Europe, driving clinical evidence generation, healthcare education and scientific communication for the Genetic Disease Testing (GDT) and Reproductive Health (RH) market segments, with the objective of increasing clinical NGS adoption, implementation in patient care, and improving patient outcomes when applicable.

Responsibilities:

• Collaborate across departments and with external stakeholders to identify and execute clinical evidence generation and educational programs.
• Partner with local teams to qualify evidence generation opportunities aligned with global and regional priorities.
• Lead cross-functional teams for successful implementation of clinical studies and educational programs.
• Define and communicate Medical Affairs priorities and key deliverables in individual studies.
• Collaborate with Marketing and others to co-develop scientific and clinical communication packages.
• Partner with various functions to ensure robust plans for market access and regulatory submissions.
• Guide regional partners on compliant execution of clinical projects and ensure regional compliance with regulations.

Preferred background, skills, and experience

• Ability to operate with a strong business mindset and make effective decisions, or decision recommendations to local teams.
• Thrive in a team environment while achieving goals independently.
• Manage scientific and clinical projects with proven expertise.
• Solve problems critically and proactively, focusing on outcomes.
• Influence and lead cross-functional teams within a matrix structure.
• Communicate effectively, conveying vision and departmental strategy.
• Master English (written & oral), with French/German a plus.
• Deliver high-quality results independently and promptly.
• PhD, PharmD, MD, or equivalent in genetic testing (outside academia).
• Strong business acumen and decision-making skills.
• Excellent teamwork, communication, and leadership abilities.
• Proven project management experience in scientific and clinical fields.
• Proactive problem-solving and critical thinking skills.
• Fluent English (written & oral), with French/German a plus.

What can you expect?

With Illumina you can expect a highly competitive salary accompanied by a market leading benefits package.  You will be part of the global leader in the Sequencing industry where you will find robust growth opportunities and career development within Illumina. 

Our team members are bright, energetic, and dedicated—they are the driving force behind our innovation and impact. To attract the best and brightest, we offer a competitive employee benefits program. We view it as a smart investment in our people, one that recognizes the tremendous value they bring to our business every day. At Illumina, we push boundaries. We think beyond the conventional. We dream big. With the energy of so many bright and accomplished people, the opportunities are endless.

All job offers with Illumina are subject to a background check. Failure to be able to supply this might result in the retraction of any job contract.

#INDEUR

#LI-EMEA

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

J&J MedTech Southeast Asia (SEA) is recruiting for a Medical Manager, SEA Scientific Affairs, located anywhere in Southeast Asia.

For more than a century of patient-centric healthcare solutions in partnership with those on the front lines, J&J has harnessed the power of technology and breakthrough innovation to elevate new standards of care. In an increasingly digital world, we are reimagining health – working to enable patient access, improve and optimize outcomes, reduce health systems costs, and drive value. In surgery, orthopedics, and interventional solutions, we go beyond what’s next to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.

We are seeking a highly motivated and experienced Medical Manager to join our diversely dynamic team of scientists at J&J MedTech Southeast Asia. The Medical Manager will play a crucial role in driving medical strategy and providing MedTech expertise within their assigned area. This individual will collaborate closely with cross-functional teams to successfully implement evidence-based programs and other omnichannel initiatives.

Key Responsibilities:

• Develop and implement medical strategies that align with company objectives and regulatory requirements.
• Provide MedTech expertise and partnership with commercial teams and other cross-functional groups.
• Serve as the key medical resource for healthcare professionals, addressing medical inquiries and providing education on products and therapies.
• Build and maintain strong relationships with key opinion leaders and professional societies/institutions within the region.
• Collaborate with internal stakeholders to develop and deliver metrics-based training programs for healthcare professionals.
• Stay abreast of industry trends, competitor activities, and regulatory changes for informed decision-making.
• Establish the evidence-generation agenda and facilitate the execution of clinical studies within the region.
• Monitor and analyze regional market trends and data to identify opportunities for growth.
• Represent the company at medical conferences, symposiums, and other relevant events.
• Ensure compliance with all relevant regulations and guidelines.

QUALIFICATIONS

Education:

• Medical/Allied Medical degree (MD, DO, or equivalent) required

Required:

• Minimum of 5 years of experience in the healthcare industry, preferably in medical affairs or a related field.
• Strong understanding of medical technology and the healthcare landscape.
• Excellent communication and interpersonal skills.
• Ability to collaborate effectively with cross-functional teams.
• Proven track record of building and maintaining relationships with key opinion leaders.
• Experience in developing and executing medical strategies.
• Ability to travel within the region as required.

Preferred:

• Board certification or equivalent in a relevant medical specialty.
• Experience in medical device or diagnostics industry.
• Advanced degree (e.g., PhD, PharmD, MBA) is a plus.
• Fluency in multiple languages is a plus.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Job Description

Role Summary

The Medical Advisor holds primary responsibility within the country for the development and execution of the Medical Affairs strategic plans and, is expected to spend up to 50% of their time in external engagements.

Key responsibilities include cross-functional strategy collaboration and execution, building trust with the medical/scientific community, facilitating peer-to-peer medical and scientific exchange, and providing asset issue resolution support.

Responsibilities and Primary Activities

Strategic and Tactical Leadership

Translates Global Medical Goals and Strategies into tactics and solutions that support optimal scientific exchange aimed at helping improve patient outcomes and enhancing access In collaboration with colleagues, facilitates the delivery of data generation activities (phases I-IV), including the identification of suitable research projects, research centers, investigators, and innovative methods to generate data Provides non-promotional, balanced, and reliable scientific information following company standards and local regulations

Medical and Scientific Leadership

Communicates scientific and business needs appropriately and effectively across internal and external stakeholders Leads country advisory boards and expert input forums

Regulatory and Market Access Support

Provides access support as needed (e.g., health technology assessment, pre-license patient access, reimbursement dossier)

Required Qualifications, Skills, & Experience

Minimum

MD, A minimum of 2-3 years of mediacal affairs exprience in relevant diaease area Experience with local pharmaceutical industry guidelines, regulatory/reimbursement framework, and clinical research guidelines Ability to effectively collaborate across functions in a matrix environment

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

(A) JOB SUMMARY

You are responsible for medical affairs and clinical matters for the hospital, which includes:

1. Providing support to the Medical Advisory Board and Continuing Medical Education Committee.

2. Oversees Doctors’ Accreditation and Credentialing, and Re-accreditation matters and to ensure that all doctors’ accreditation status is updated timely.

3. Manages medico-legal matters and Serious Reportable Events promptly and according to timeline.

(B) PRIMARY DUTIES & RESPONSIBILITIES

1. To be the secretariat for Medical Advisory Board meetings, which include scheduling of meetings, minute taking and any other related matters in accordance with the Terms or Reference.

2. To be the secretariat of any ad-hoc Quality Assurance Committee (Including Committee of Inquiry) that may arise from time to time when there are cases for deliberation and discussion within the Medical Advisory Board and its subcommittees.

3. Risk manage and de-escalate medico-legal matters and Serious Reportable Events (SREs), including but not limited to:

a. Clinical Cases

• Maintaining records and data of medical incidents to:
• Summarize the information gathered from all stakeholders and prepare both preliminary and final reports (incorporating the views of expert opinion and legal advice provided) on the position adopted by the hospital and its rationale.
• Corresponding appropriately with hospital’s appointed legal advisors.
• If necessary, submit the MARSH report form to the hospital’s appointed insurers as and when necessary.
• Submit data timely to the National Quality Assurance System (NQAS) according to the stipulated timeline for all SRE cases.
• For medico-legal cases, to monitor and respond timely to all enquiries and follow-up actions from hospital appointed legal advisors or any other parties involved.
• Ensure prompt communication to patient or their next-of-kin as and when required.

b. Management of queries relating to Clinical Operations

• Respond to queries relating to Clinical Operations policies from both internal and external parties and maintain the query database.
• Assist in the preparation for any MOH Licensing and Accreditation Audits.
• Timely submission of data into Healthcare Application and Licensing Portal (HALP).
• Follow-up closely with all stakeholders for data submission prior to hospital inspection for Annex A submission and preparing Annex B for actual inspection.

4. Work closely with Quality Management Department for smooth hospital inspection by the MOH team.

5. Keep close tracking for all incoming emails from MOH and disseminate timely to Senior Management and all stakeholders for follow-up actions.

6. Work closely with Administrative Executive to administer Doctor’s applications for Accreditation and Credentialing and Re-accreditation including maintaining the master files and database of the accredited doctors to be updated timely. Ensure that all licenses, memberships, and certificates are renewed and valid at all times.

7. Support Doctor’s engagement and relationship building, including the administration of Continuing Medical Education (CME) activities such as organizing of medical talks / seminars / workshops for doctors and CME points submission.

8. Disseminate timely notification to doctors when there are urgent updates on hospital’s matters such as disruption to pharmaceutical items, etc.

(C) SECONDARY DUTIES & RESPONSIBILITIES

1. Any other duties and responsibilities that may be assigned by the Reporting Officer and company from time to time based on the company’s needs.

2. To take on any other special projects as assigned.

(D) KEY JOB SPECIFICATIONS

• Relevant tertiary qualification. Degree in any disciple.
• Medical / Nursing / Healthcare Management degree preferred.
• Minimum 5 years of relevant experience in healthcare services managing medical affairs portfolio preferred.

Job Description

General Summary:

The Medical Affairs Senior Manager will contribute to the delivery of the Medical Plans in the international region and ensure execution of assigned medical affairs tactics that are aligned with the overall medical strategy. This role will be working across two therapeutic areas: Haematology and CF.

Key Duties and Responsibilities:

• Provides key support for the Medical brand team in the assigned region
• Supports the development of Medical Plans for the assigned country/region and ensures execution of Medical affairs tactics that are aligned with the overall medical strategy
• Supports the development, maintenance and distribution of resources to address identified medical needs, and is responsible for the accuracy and appropriateness of the materials.
• Delivers scientific presentations to diverse audiences, both internal and external (e.g. physicians, pharmacists, marketing/medical agencies, and other key stakeholders) in meeting, advisory and/or consulting settings
• Interfaces with multiple internal functions as a key component of the medical brand team for the assigned region, as well as with Medical Science Liaisons (MSLs), Commercial functions, Regulatory Affairs, among other, as well as external partners and physicians in the community.

Knowledge and Skills:

• Ability to develop/review resources to address identified medical needs, ensuring the accuracy and appropriateness of the materials.
• Ability to work effectively in a highly matrix environment and have a successful track record of supporting project strategies and executing project details.
• Ability to work effectively in a fast-paced and ever-changing environment
• Proven track record of developing internal relationships and working effectively with cross-functional partners in a highly matrix environment
• Demonstrated ability in driving results to a positive outcome
• Possess the ability to engage in positive dialogues, influence outcomes and resolve conflicts in a constructive manner
• Knowledge of industry codes e.g. EFPIA and ABPI

Education and Experience:

• Advanced medical or scientific degree (e.g. MD, PharmD, PhD, MSc, etc.)
• Previous experience in biotech/pharma at regional level desirable      
• Experience as a final signatory

Company Information

Job Description

Regulatory Affairs Manager - Animal Health

• Opportunity to be a part of a global Regulatory Affairs – General organization in Malaysia!
• Based in Malaysia, top-ranked biopharmaceutical company on The Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
• Join the premier biopharmaceutical company that has been in Malaysia for more than 25 years and in AP for over 60 years.

Primary Responsibilities

Regulatory

• Product registration

• Plan, manage and oversee RA activities within the coverage region

• Manage and oversee all product’s regulatory lifecycle process; submission; approval and maintenance activities (variation, renewal) in relation to the following national regulatory authorities as follows:

Malaysia

- Department of Veterinary Services (DVS) Putrajaya, Sabah & Sarawak, MoA

- National Pharmaceutical Regulatory Agency (NPRA), MoH

- Pharmaceutical Services Division (BPF), MoH

- Pesticides Board, MoA

Singapore

- Animal & Veterinary Services (AVS) / National Parks Board (NPARKS), MoA

Brunei

- Division of Livestock and Veterinary Service, MoA

- Department of Fisheries, MoA

• Act as Poison A (Wholesale) License holder
• Assess registration feasibility and acceptability of products for importation
• Registration timeline setting and communication to RA team as well as local and global cross-functional units
• Identify data needed, prepare and/or obtain data and review to ensure that they are effectively presented for the registration of product
• Interact with and present to national regulatory authorities on regulatory related new product submissions strategies and maintenance of current product portfolio, as applicable
• Manage positive networking relationship with national regulatory authorities as necessary
• Provide regulatory review of variation proposals, labeling and additional submission documents
• Assess regulatory of product variations on product lifecycle and communicate as necessary to line-management and cross functional teams
• Collaborate with global regulatory affairs functions to develop global regulatory submission and approval strategies
• Provide correspondence to national regulatory authority enquiry(s) for products responsible
• Provide regulatory advice and guidance to line-management and cross functional teams to ensure product submissions and importations meet regulatory requirements
• Review and verify packaging labels where applicable, revise labels by using PDF program per local regulatory authority requirement for registration and importation
• Develop SOPs and provide regulatory input to product life-cycle planning
• Manage secondary repackaging procedures in line with SOPs and regulatory requirements
• Maintain up-to-date legal and regulatory knowledge on the registration, import and sale of products.
• Oversee and develop a team of highly motivated, experienced and dedicated direct reports

Education Minimum Requirement:

• Graduates with Science related degree eg. Veterinary science / Animal science BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.
   

Required Experience and Skills:

• 5-7 years in Regulatory Affairs of Animal Health industries
• Experienced in handling registration of veterinary biological products, dealing with Department of Veterinary Services (DVS).
• Veterinarian or Pharmacist are welcome

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

About the unit

This Labor and Delivery Unit does approximately 750 deliveries per year greater than 34 weeks gestation.  This position includes leadership over the Special Care Nursery, and Postpartum unit as well.

About Farmington Hills Hospital

Recognized by U.S News and World Report as one of the nation’s high-performing facilities for multiple procedures and conditions and has been recognized as a Magnet-designed hospital for nursing excellence. This hospital has grown in size and capabilities over the decades to become a Level II trauma center, serving the community since 1965. It also serves as the base teaching hospital for Michigan State University. 

Scope of work 

Under general direction, maintains 24-hour responsibility and accountability for providing leadership and management of a designated patient care unit which promotes quality nursing care, cost effective use of resources and professional growth for nursing staff. Promotes a Patient Family Centered Care Culture.

How we will care for you, while you care for our patients

Comprehensive benefits package to meet your financial, health, and work/life balance goals. Learn more here.

On-demand pay program powered by Payactiv

Discounts directory with deals on the things that matter to you, like restaurants, phone plans, spas, and more!

Optional identity theft protection, home and auto insurance, pet insurance

Traditional and Roth retirement options with service contribution and match savings

Free onsite parking

Qualifications

• Required Bachelor's Degree in nursing.
• Preferred Master's Degree
• Required Completion of a Nurse Executive Council approved leadership development educational program.
• 3 years of relevant experience. Minimum of 3 years of clinical nursing experience. Required
• 1 year of relevant experience Minimum of one year of formal nursing leadership experience required for external applicants. Required
• 2 years of relevant experience Minimum of 2 years demonstrated informal leadership experience required for internal applicants, may include but are not limited to: Charge Lead Nurse, Charge Nurse responsibilities, leadership on behalf of unit/site/system at Shared Governance Council, etc. Required
• LIC-Registered Nurse (RN) - STATE_MI State of Michigan Upon Hire required
• CRT-Specialty Certification - UNKNOWN Unknown 2 Yrs required

Primary Location

SITE - Farmington Hills Hospital- 28050 Grand River Ave - Farmington Hills

Department Name

Nursing Mother Baby Care Unit - Farmington Hills

Employment Type

Full time

Shift

Day (United States of America)

Weekly Scheduled Hours

40

Hours of Work

7a.m. - 3:30p.m.

Days Worked

Variable

Weekend Frequency

On-call weekends

CURRENT COREWELL HEALTH TEAM MEMBERS – Please apply through Find Jobs from your Workday team member account. This career site is for Non-Corewell Health team members only.

Corewell Health is committed to providing a safe environment for our team members, patients, visitors, and community. We require a drug-free workplace and require team members to comply with the MMR, Varicella, Tdap, and Influenza vaccine requirement if in an on-site or hybrid workplace category. We are committed to supporting prospective team members who require reasonable accommodations to participate in the job application process, to perform the essential functions of a job, or to enjoy equal benefits and privileges of employment due to a disability, pregnancy, or sincerely held religious belief.

Corewell Health grants equal employment opportunity to all qualified persons without regard to race, color, national origin, sex, disability, age, religion, genetic information, marital status, height, weight, gender, pregnancy, sexual orientation, gender identity or expression, veteran status, or any other legally protected category.

An interconnected, collaborative culture where all are encouraged to bring their whole selves to work, is vital to the health of our organization. As a health system, we advocate for equity as we care for our patients, our communities, and each other. From workshops that develop cultural intelligence, to our inclusion resource groups for people to find community and empowerment at work, we are dedicated to ongoing resources that advance our values of diversity, equity, and inclusion in all that we do. We invite those that share in our commitment to join our team.

You may request assistance in completing the application process by calling 616.486.7447.

• Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.
• Collaborate with cross-functional teams including R&D, Quality Assurance, and Legal to ensure that all regulatory requirements are met
• Prepare and submit regulatory submissions
• Liaise with regulatory authorities and act as the primary point of contact during inspections, audits, and regulatory agency interactions.
• Review and approve product labelling, promotional materials, and other relevant documentation
• Provide regulatory guidance and support to internal stakeholders

Requirements:

• Minimum Degree in related courses and above
• Prior 3 years of RA Manager experience in pharma MNCs
• Able to start immediate or within short notice

If you meet the requirements of this role, please email a detailed resume in Word document to Cindy Wong Xinyi

CEI Registration No.: R2095121

Email: cindywong@recruitexpress.com.sg

Tel: 9666 7710

*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

EA License No: 99C4599

EA Personnel No: R2095121

EA Personnel Name: Cindy Wong Xin Yi

     

JOB DESCRIPTION:

DO WORK THAT MATTERS.

Medical & Scientific Affairs Manager Middle East/ Eastern

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Egypt affiliate in the Rapid diagnostics division. In this division our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges. Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe.

As the Medical & Scientific Affairs Manager Middle East/ Eastern Europe , you’ll have the chance to upports the strategy of enhancing Abbott Rapid Diagnostics (ARDx) medical & scientific leadership within the Middle East and Eastern Europe Regions.

What You’ll Do

• Supports commercial organizations with medical & scientific input, customer interactions and scientific presentations
• Leads efforts to define and implement new medical strategies for the (applicable business area) e.g.;
• Lateral Flow Infectious Disease assays and molecular product area.
• Executes annual plan.
• Identifies and establishes relationships with opinion leaders involved in disease states or technical initiatives.
• Identifies sites; negotiates contracts; writes study protocols; monitors study progress; analyses results and works with investigators to publish papers by ARDx.
• Work and publications must be accepted as medically important and useful in moving accepted science
• forward and/or influencing medical policy.
• Prepares medical posters and abstracts and presents at key professional meetings around the world.
• Part of cross functional team involved in developing patient and physician education materials.
• Works with R&D scientists to identify and evaluate markers for new disease areas or product improvements, technologies and intellectual properties.
• Acts as a liaison between Customers/Quality/Regulatory and technical organizations when medical /scientific issues arise.
• Must comply with and enforce all OEC guidelines.
• Designs and manages Abbott-initiated and investigator-initiated scientific studies
• Analyses results of scientific studies and produces publications and conference presentations
• Builds relationships with key opinion leaders and applies their input to enhance study design and protocols, as well as product requirements and product feasibility
• Assures that the scientific research program meets scientific and business objectives
• Partners across the business on technical, scientific, marketing, commercial, and quality programs and initiatives
• Partner across the business to address on market product issues
• Supports R&D with input to product development and performance

Required Qualifications

• Bachelor’s degree or equivalent in one of the following areas:
  • A qualification as a registered Doctor or PhD or Pharmaci

Preferred Experience

• 5 years Medical Affairs management experience.
• 2-4 years business unit or general management experience.
• Knowledge of regulations and standards affecting IVDs and Biologics.
• Must have previously developed external relationships with key scientists or medical professionals.
• Industry, product and customer knowledge required
• Must have strong interpersonal skills
• Good communication skills
• Medical writing skills.
• Demonstrated leadership capabilities
• Excel
• Statistical software

Apply Now

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Medical & Scientific Affairs

     

DIVISION:

IDEM ARDx Infectious Disease Emerging Markets

        

LOCATION:

Egypt : Remote

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 75 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

     

     

     

We’re hiring an APAC Medical Affairs Manager to join us, who will play a critical role in bridging the gap between the APAC medical and commercial aspects in AmoyDx.

Job responsibilities:

· Medical Strategy Development:

o Develop and implement medical affairs strategies in alignment with overall business goals.

o Provide input into the development of medical plans, ensuring integration with marketing and sales strategies.

· Scientific Communication:

o Serve as a key point of contact for scientific and medical information within the organization.

o Develop and review scientific content for medical communications, educational materials, and promotional activities.

· Pharma partners and KOL Engagement:

o Identify and engage with pharma partners, Key Opinion Leaders (KOLs) and other stakeholders to foster relationships and gather insights.

o Collaborate with KOLs to support educational initiatives, advisory boards, and research collaborations.

· Regulatory Support:

o Work closely with the regulatory affairs team to ensure compliance with relevant regulations and guidelines.

o Support the preparation of regulatory submissions by providing scientific and medical input.

· Clinical Support:

o Provide medical input into the development of clinical trial protocols and study designs.

o Collaborate with clinical operations to ensure the successful execution of clinical trials.

· Training and Education:

o Develop and deliver training programs for internal stakeholders, including sales teams and customer support.

o Stay informed about advancements in medical science and ensure the organization's teams are educated on relevant topics.

· Collaboration with Cross-Functional Teams:

o Work collaboratively with marketing, sales, market access, and other departments to ensure consistent messaging and alignment of activities.

· Data Analysis:

o Analyze and interpret scientific and clinical data to inform decision-making and support product positioning.

· Budget Management:

o Manage the medical affairs budget, ensuring efficient use of resources and adherence to financial guidelines.

· Compliance:

o Ensure that all medical affairs activities adhere to relevant compliance standards, industry codes, and regulations.

Requirement:

· Medical degree

· Experience working with pharmaceutical industry is highly preferred.

· Minimum of 5 - 7 years of experience in medical affairs

· Strong understanding of medical and scientific principles, as well as regulatory requirements.

· Excellent communication and presentation skills.

· Ability to work collaboratively in cross-functional teams.

· Strong project management and organizational skills

Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.

At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our mission is to put the patients first through innovation.

Over 30 years we have developed our HaemaFrac™ process which enables countries to turn human plasma they collected into life saving hyperimmune products.

It's no secret that Aegros is expanding rapidly! An exciting opportunity has arisen for a Medical Affairs Manager to join our team. Reporting to the Chief Medical Officer, you will be responsible for overseeing scientific and medical support across the business contributing to product development and lifecycle management.

In this role you will be instrumental in driving state of the art medical insight in the plasma-derived medicinal products therapy areas and working with key opinion leaders (internal and external) and networks of medical and clinical contacts.

What you will be involved in………

• Provide comprehensive scientific and medical support across plasma derived products therapy areas providing insights to facilitate product development and lifecycle management.
• Serve as the primary expert in therapy and product knowledge internally and externally representing the organization to stakeholders.
• Design and implement Medical Plans in alignment with internal stakeholders.
• Establish and nurture robust relationships with KOLs, government representatives, and healthcare organizations to incorporate valuable insights into strategic decision-making.
• Ensure strict compliance with industry standards in material review and promotional activities.
• Maintain the highest ethical and legal standards in all engagements.
• The role is an office based MSL with an expectation of up to 50% field work.

What we would expect from you:

• Scientific PhD, Pharmacy, Medical qualifications or related degree
• At least 3 - 5 years in medical affairs and related roles within pharmaceutical industry.
• Experience in medical compliance such as Medicines Australia, PHRMA or EFPIA codes, and related jurisdictional regulations and guidelines.
• Previous experience in haematology, immunology or plasma fractionation desirable.
• Intermediate/advanced knowledge of Office suite; conversant with key sites on Internet; conversant with key medical databases and able to implement basic search strategies
• Flexible and adapts well to change.
• Keeps up to date with the new data and changing healthcare environment.

Here’s what we can offer you…

• An environment which allows the individual to grow alongside the company
• A role that provides the bandwidth to explore innovative solutions while keeping patients at the centre of everything we do
• The chance to work with global industry experts in an organisation where success will be defined not just on successful delivery of goals but on how they were achieved
• A multicultural environment where every voice is heard
• Competitive remuneration package which includes an annual Bonus + Employee Share Options
• Close to public transport.

Interested? Apply today...!!!!